Diabetic Foot, Foot Ulcer, Leg Ulcer, Varicose Ulcer, Venous Hypertension Ulcers, Venous Insufficiency, Venous Stasis Ulcer, Venous Ulcer
Conditions
Keywords
post healed venous leg ulcer, posted healed diabetic foot ulcer
Brief summary
The goal of this study is to test MUSTCOOL, a home-based self-monitoring and self-management ulcer prevention intervention for patients with newly healed chronic venous leg and diabetic foot ulcers. Almost 90% of ulcers recur within 3 months of healing. During the six-month randomized clinic trial, skin temperature will be monitored daily, a maintenance dose of cooling gel pack or placebo will be applied three times weekly to the affected skin, and a bolus dose of cooling will be applied for 5 consecutive days if skin temperature becomes elevated. Outcomes on the incidence of leg ulcer recurrence, pain, physical activity and quality of life will be measured.
Detailed description
The goal of this randomized control trial is to test a patient directed self-monitoring and self-management intervention aimed at preventing the recurrence of chronic venous leg and diabetic foot ulcers using skin temperature and cryotherapy (cooling). This MUSTCOOL study is a novel ulcer prevention strategy for patients at highest risk for developing chronic ulcers; those with a previous history. The aims are to compare a cooling treatment to a placebo to determine the outcomes on ulcer recurrence, pain, physical activity and quality of life. Individuals with newly healed chronic ulcers will be invited to participate in MUSTCOOL's two component intervention: 1. self monitoring skin temperature over targeted hot spots daily with an infrared thermometer; and 2. maintenance cooling with a cooling pack (or placebo pack) placed over the hot spot three times each week for 30 minutes. If the temperature of the hot spot becomes elevated 2°F above baseline (average of 30 days of daily temperature readings) for 2 days in a row, a bolus regimen of 5 consecutive daily, 30 minute applications of the cooling or placebo pack will be implemented. The safety and side effects will be monitored, however, there have been no reported adverse events reported in our previous cryotherapy studies. This study was designed as a chronic ulcer prevention intervention that targets the remodeling phase, the final repair process of healing after chronic ulcer closure. The skin environment is particularly vulnerable to ulcer recurrence due to a persistent aberrant inflammatory state. The previous research conducted by the study team has demonstrated that cooling this skin reduces the abnormal metabolic activity, protecting it against ulcer recurrence. Recent advancements in infrared technology allow us to take images of the affect skin to identify the area that has the highest temperature or vulnerable hot spot. These hot spots will be self monitored by patients with newly healed ulcers in the home with an infrared thermometer that date and time stamps each reading. The study's outcomes on physical activity will be evaluated with an accelerometer. It is hypothesized that by improving the skin environment and reducing pain, patients will more likely be physically active and have better quality of life, all measurable goals for this study. This prevention strategy will be evaluated over six months in 180 patients, 90 of whom will be randomized to receive the cooling pack and 90 the placebo. The goal is to test this non-pharmacological, non-invasive clinical intervention as a tailored self-management strategy to prevent chronic ulcer recurrence. It will also determine alleviation of symptoms such as pain, and the debilitating effects on physical activity and quality of life.
Interventions
DEVICECooling gel pack
Individuals will self monitor skin temperature of skin over a recently health venous leg or diabetic foot ulcer with a dermal thermometer. A cooling gel pack will be applied to skin of recently healed venous leg or diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increases and stays elevated 2°F above the usual temperature of that site, the individual will cool the skin 5 consecutive days and will continue to monitor skin temperature.
DEVICECooling cotton pack
Individuals will self monitor skin temperature of skin over a recently health venous leg or diabetic foot ulcer with a dermal thermometer. A cotton filled pack will be applied to skin of recently healed venous leg or diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increases and stays elevated 2°F above the usual temperature of that site, the individual will cool the skin 5 consecutive days and will continue to monitor skin temperature.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Newly healed leg or diabetic foot ulcer within past 7 - 14 days * Ankle brachial index 0.8- 1.3mmHg (rule out absence of arterial disease) * Willing to wear compression stockings and appropriate footwear * Working freezer
Exclusion criteria
* Open leg or foot ulcers * Cognitive impairment: unable to recall 2 or more words or draw clock Mini-Cog™ for cognitive impairment * Chronic inflammatory or vascular conditions where blood flow of skin may be impaired such as Lupus erythematosus, Raynaud's, scleroderma, end stage renal disease, chronic regional pain syndrome, multiple sclerosis, hypersensitivity to cold, on chemotherapy * Unable to preform required protocol activities without assistance (return demonstration to study staff)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Spent in Minutes Engaging in Physical Activities | Through study completion at 6 months from baseline | Mean time spent in minutes engaging in physical activities, reported via accelerometer data, from baseline to post treatment at 6 months end of intervention for the 4 groups. |
| Change in Mean Scores on Quality of Life Measured With the VEINES QOL/Sym Questionnaire | Through study completion at 6 months from baseline | The Venous Insufficiency Epidemiological and Economic Study-Quality of life/Symptoms (VEINES QOL/Sym) Questionnaire was used to evaluate quality of life. A sum score is provided as an overall quality of life score for both the QOL and Sym portions of the questionnaire. This instrument was used only for the VLU groups because it is a disease-specific measure. Of the 26 items in the questionnaire, 25 items are combined to create a summary score (VEINES-QOL). One item which asks about the time of day the leg problem is most intense, question 2, provides only descriptive information and is not scored. A subset (symptoms score) of ten of these items, questions 1a to 1i and 7, is used to create a symptom score (VEINES-Sym). For both the VEINES-QOL and VEINES-Sym scores, high values indicate better outcomes. VEINES-QOL scores can be compared only to other members of the same sample. Each set of VEINES-QOL scores will have a mean T-score = 50. |
| Changes in Severity and Intensity Pain Scores Measured With the Brief Pain Inventory | Through study completion at 6 months from baseline | The Brief Pain Inventory (BPI) scale is reported as an average score. BPI rapidly assesses the severity of pain and its impact on functioning for intensity and Pain Intensity and Pain Interference. Pain Intensity is measured in four categories: worst, least, on average, and currently, while Pain Interference is measured in 7 categories: mood, work, general activity, walking, relationships, enjoyment of life, and sleep. The patient rates each of these on a scale from 0-10, 10 being excruciating pain intensity and a complete interference in their life. Subscores are determined by averaging over the 4 intensity items for the severity subscore and over the 7 interference items for the interference subscore; possible total scores range from 0 to 10. Higher scores indicate worse intensity and severity. |
| Change in METS Minutes Engaging in Physical Activity Measured With The International Physical Activity Questionnaire | Through study completion at 6 months from baseline | Change in metabolic equivalent of task (METS) min per week for physical activity per The International Physical Activity Questionnaire reported for 4 groups from baseline to 6 months end of study. Scoring HIGH indicate physical activity levels equate to \ 1hour of activity per day or more at least moderate intensity level or engage in vigorous intensity activity on at least 3 days achieving a minimum total physical activity of at least 1500 MET min a week or 7 or more days of any combination of walking, moderate intensity or vigorous intensity activities achieving a minimum total physical activity of at least 3000 MET min a week. MODERATE suggests engagement equivalent to 30 min of at least moderate intensity activity on most days; engage in 3 or more days of vigorous intensity activity and/or walking of at least 30 min per day or 5 or more days of moderate intensity activity and/or walking of at least 30 minutes per day. LOW level means that neither MODERATE or HIGH levels are met. |
| Number of Participants With Ulcer Recurrence | Through study completion at 6 months from baseline | Number of recurrent ulcers that develop during the 6 month study period for in participants for 4 groups of patients with previously healed venous leg ulcers receiving the cooling gel pack and cooling cotton pack and those with previously healed diabetic foot ulcers receiving the cooling gel pack or cooling cotton pack. |
| Change in Pain (Worst Pain, Least Pain, Pain Now) | Through study completion at 6 months from baseline | Pain was measured with a visual analog scale and reported numerically (0 to 10 with 10 being the most severe pain) at baseline and at 6 months end of study |
| Differences in Step Counts | Through study completion at 6 months from baseline | Differences in step counts reported via accelerometer data, from baseline to post treatment at 6 months end of intervention for the 4 groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Survey conducted at end of the 6-month study period. | Patients satisfaction was measured by study personnel a during end of study phone survey with the following questions asked as follows (Yes/No): Were study instructions adequate, was thermometer easy to use, found cooling helpful, would cool skin area if it was proven that cooling prevented reulceration; (Easy/Not Easy): completing logs, performing the cooling treatment. Data are for (Yes/No) as number of participants who reported yes or if (Easy/Not Easy) the number of participants who reported easy. |
| Knowledge Questionnaire of Study Instructions | Baseline after participant enrollment | Participants were administered a 12-item (yes/no) questionnaire (test) during instruction at the start of the study, provided by the research personnel to determine comprehension of the protocol and to reinforce study procedures. Score of 12 or 100% was given for all items scoring correctly (1 point per item). Any items for which no was answered, remediation was conducted by study personnel at the time the questionnaire was conducted. Means scores are reported per VLU and DFU cooling pack intervention and VLU and DFU cotton cooling pack control. |
| Participant Adherence to the Study Protocol | Daily measures starting at baseline for temperature and every other day cooling application during the 6-month study period. | Using study data logs, appropriate use of the thermometer and cooling pack was measured by the number of participants who adhered to the protocol for taking the temperature of the skin over the healed venous leg or diabetic foot ulcer. Adherence was defined as: the number of participants who were at least 80% adherent to taking their temperatures with the infrared thermometer each morning and the number of participants who were at least 80% adherent to performing the intervention every other day = 3 times times per week during the 6-month study period. |
Countries
United States
Participant flow
Recruitment details
Date recruitment period was January 2017 through December 2019 at wound clinics in the South and North Carolina areas including Charleston SC, Spartanburg SC and Greenville NC via clinicians practicing in those clinics and flyers were distributed in and around community settings such as senior centers, prior to approval from MUSC IRB.
Pre-assignment details
246 individuals approached, 211 prescreened eligible, 71 ineligible due to type of wound, could not make regular appointments for study visits, not interested in study, lost contact or developed infection or ulcer changed in size (healed or enlarged indicating deterioration prior to eligibility screening visit); 140 were enrolled - 58 in the DFU group (29 intervention and 29 control)and 82 in VLU group (42 intervention and 40 control)
Participants by arm
| Arm | Count |
|---|---|
| Cooling Gel Pack - Venous Leg Ulcer A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | 42 |
| Cooling Cotton Pack - Venous Leg Ulcer A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | 40 |
| Cooling Gel Pack - Diabetic Foot Ulcer A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | 29 |
| Cooling Cotton Pack - Diabetic Foot Ulcer A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | 29 |
| Total | 140 |
Baseline characteristics
| Characteristic | Cooling Gel Pack - Venous Leg Ulcer | Total | Cooling Cotton Pack - Diabetic Foot Ulcer | Cooling Gel Pack - Diabetic Foot Ulcer | Cooling Cotton Pack - Venous Leg Ulcer |
|---|---|---|---|---|---|
| Age, Continuous | 64.2 years STANDARD_DEVIATION 14.7 | 62.4 years STANDARD_DEVIATION 12.9 | 61.3 years STANDARD_DEVIATION 11.6 | 57.8 years STANDARD_DEVIATION 11.7 | 64.8 years STANDARD_DEVIATION 12.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 7 Participants | 1 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 133 Participants | 28 Participants | 26 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 47 Participants | 5 Participants | 8 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 91 Participants | 24 Participants | 20 Participants | 26 Participants |
| Region of Enrollment United States | 42 participants | 140 participants | 29 participants | 29 participants | 40 participants |
| Sex: Female, Male Female | 23 Participants | 54 Participants | 9 Participants | 5 Participants | 17 Participants |
| Sex: Female, Male Male | 19 Participants | 86 Participants | 20 Participants | 24 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 42 | 0 / 40 | 0 / 29 | 0 / 29 |
| other Total, other adverse events | 14 / 42 | 7 / 40 | 15 / 29 | 10 / 29 |
| serious Total, serious adverse events | 4 / 42 | 2 / 40 | 3 / 29 | 4 / 29 |
Outcome results
Primary
Change in Mean Scores on Quality of Life Measured With the VEINES QOL/Sym Questionnaire
The Venous Insufficiency Epidemiological and Economic Study-Quality of life/Symptoms (VEINES QOL/Sym) Questionnaire was used to evaluate quality of life. A sum score is provided as an overall quality of life score for both the QOL and Sym portions of the questionnaire. This instrument was used only for the VLU groups because it is a disease-specific measure. Of the 26 items in the questionnaire, 25 items are combined to create a summary score (VEINES-QOL). One item which asks about the time of day the leg problem is most intense, question 2, provides only descriptive information and is not scored. A subset (symptoms score) of ten of these items, questions 1a to 1i and 7, is used to create a symptom score (VEINES-Sym). For both the VEINES-QOL and VEINES-Sym scores, high values indicate better outcomes. VEINES-QOL scores can be compared only to other members of the same sample. Each set of VEINES-QOL scores will have a mean T-score = 50.
Time frame: Through study completion at 6 months from baseline
Population: Due to inadvertent scoring errors, there were data for 8 individuals.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cooling Gel Pack - Venous Leg Ulcer | Change in Mean Scores on Quality of Life Measured With the VEINES QOL/Sym Questionnaire | Quality of life | 13.8 t-scores |
| Cooling Gel Pack - Venous Leg Ulcer | Change in Mean Scores on Quality of Life Measured With the VEINES QOL/Sym Questionnaire | Symptoms | 24.2 t-scores |
| Cooling Cotton Pack - Venous Leg Ulcer | Change in Mean Scores on Quality of Life Measured With the VEINES QOL/Sym Questionnaire | Quality of life | -4.8 t-scores |
| Cooling Cotton Pack - Venous Leg Ulcer | Change in Mean Scores on Quality of Life Measured With the VEINES QOL/Sym Questionnaire | Symptoms | -4.3 t-scores |
Primary
Change in METS Minutes Engaging in Physical Activity Measured With The International Physical Activity Questionnaire
Change in metabolic equivalent of task (METS) min per week for physical activity per The International Physical Activity Questionnaire reported for 4 groups from baseline to 6 months end of study. Scoring HIGH indicate physical activity levels equate to \ 1hour of activity per day or more at least moderate intensity level or engage in vigorous intensity activity on at least 3 days achieving a minimum total physical activity of at least 1500 MET min a week or 7 or more days of any combination of walking, moderate intensity or vigorous intensity activities achieving a minimum total physical activity of at least 3000 MET min a week. MODERATE suggests engagement equivalent to 30 min of at least moderate intensity activity on most days; engage in 3 or more days of vigorous intensity activity and/or walking of at least 30 min per day or 5 or more days of moderate intensity activity and/or walking of at least 30 minutes per day. LOW level means that neither MODERATE or HIGH levels are met.
Time frame: Through study completion at 6 months from baseline
Population: A total of 140 participants were randomized, with a final completion for this outcome of 82 individuals (59%)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cooling Gel Pack - Venous Leg Ulcer | Change in METS Minutes Engaging in Physical Activity Measured With The International Physical Activity Questionnaire | 73 minutes |
| Cooling Cotton Pack - Venous Leg Ulcer | Change in METS Minutes Engaging in Physical Activity Measured With The International Physical Activity Questionnaire | 799 minutes |
| Cooling Gel Pack - Diabetic Foot Ulcer | Change in METS Minutes Engaging in Physical Activity Measured With The International Physical Activity Questionnaire | 1921 minutes |
| Cotton Cooling Pack - Diabetic Foot Ulcer | Change in METS Minutes Engaging in Physical Activity Measured With The International Physical Activity Questionnaire | 225 minutes |
Primary
Change in Pain (Worst Pain, Least Pain, Pain Now)
Pain was measured with a visual analog scale and reported numerically (0 to 10 with 10 being the most severe pain) at baseline and at 6 months end of study
Time frame: Through study completion at 6 months from baseline
Population: A total of 140 participants were randomized, with a final completion for this outcome of 83 individuals (59%)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cooling Gel Pack - Venous Leg Ulcer | Change in Pain (Worst Pain, Least Pain, Pain Now) | Pain now | 0.4 score on a scale |
| Cooling Gel Pack - Venous Leg Ulcer | Change in Pain (Worst Pain, Least Pain, Pain Now) | Least pain | 0.3 score on a scale |
| Cooling Gel Pack - Venous Leg Ulcer | Change in Pain (Worst Pain, Least Pain, Pain Now) | Worst pain | 0.85 score on a scale |
| Cooling Cotton Pack - Venous Leg Ulcer | Change in Pain (Worst Pain, Least Pain, Pain Now) | Pain now | 0.14 score on a scale |
| Cooling Cotton Pack - Venous Leg Ulcer | Change in Pain (Worst Pain, Least Pain, Pain Now) | Worst pain | 0.4 score on a scale |
| Cooling Cotton Pack - Venous Leg Ulcer | Change in Pain (Worst Pain, Least Pain, Pain Now) | Least pain | 0 score on a scale |
| Cooling Gel Pack - Diabetic Foot Ulcer | Change in Pain (Worst Pain, Least Pain, Pain Now) | Worst pain | 0 score on a scale |
| Cooling Gel Pack - Diabetic Foot Ulcer | Change in Pain (Worst Pain, Least Pain, Pain Now) | Pain now | 0.1 score on a scale |
| Cooling Gel Pack - Diabetic Foot Ulcer | Change in Pain (Worst Pain, Least Pain, Pain Now) | Least pain | -0.1 score on a scale |
| Cotton Cooling Pack - Diabetic Foot Ulcer | Change in Pain (Worst Pain, Least Pain, Pain Now) | Least pain | 0 score on a scale |
| Cotton Cooling Pack - Diabetic Foot Ulcer | Change in Pain (Worst Pain, Least Pain, Pain Now) | Pain now | -0.1 score on a scale |
| Cotton Cooling Pack - Diabetic Foot Ulcer | Change in Pain (Worst Pain, Least Pain, Pain Now) | Worst pain | -1.0 score on a scale |
Primary
Changes in Severity and Intensity Pain Scores Measured With the Brief Pain Inventory
The Brief Pain Inventory (BPI) scale is reported as an average score. BPI rapidly assesses the severity of pain and its impact on functioning for intensity and Pain Intensity and Pain Interference. Pain Intensity is measured in four categories: worst, least, on average, and currently, while Pain Interference is measured in 7 categories: mood, work, general activity, walking, relationships, enjoyment of life, and sleep. The patient rates each of these on a scale from 0-10, 10 being excruciating pain intensity and a complete interference in their life. Subscores are determined by averaging over the 4 intensity items for the severity subscore and over the 7 interference items for the interference subscore; possible total scores range from 0 to 10. Higher scores indicate worse intensity and severity.
Time frame: Through study completion at 6 months from baseline
Population: A total of 140 participants were randomized, with a final completion for this outcome of 83 individuals (59%)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cooling Gel Pack - Venous Leg Ulcer | Changes in Severity and Intensity Pain Scores Measured With the Brief Pain Inventory | Severity | -0.5 score on a scale |
| Cooling Gel Pack - Venous Leg Ulcer | Changes in Severity and Intensity Pain Scores Measured With the Brief Pain Inventory | Interference | -0.4 score on a scale |
| Cooling Cotton Pack - Venous Leg Ulcer | Changes in Severity and Intensity Pain Scores Measured With the Brief Pain Inventory | Interference | -0.5 score on a scale |
| Cooling Cotton Pack - Venous Leg Ulcer | Changes in Severity and Intensity Pain Scores Measured With the Brief Pain Inventory | Severity | -0.2 score on a scale |
| Cooling Gel Pack - Diabetic Foot Ulcer | Changes in Severity and Intensity Pain Scores Measured With the Brief Pain Inventory | Severity | 0 score on a scale |
| Cooling Gel Pack - Diabetic Foot Ulcer | Changes in Severity and Intensity Pain Scores Measured With the Brief Pain Inventory | Interference | -0.1 score on a scale |
| Cotton Cooling Pack - Diabetic Foot Ulcer | Changes in Severity and Intensity Pain Scores Measured With the Brief Pain Inventory | Severity | 0.4 score on a scale |
| Cotton Cooling Pack - Diabetic Foot Ulcer | Changes in Severity and Intensity Pain Scores Measured With the Brief Pain Inventory | Interference | 0.1 score on a scale |
Primary
Differences in Step Counts
Differences in step counts reported via accelerometer data, from baseline to post treatment at 6 months end of intervention for the 4 groups.
Time frame: Through study completion at 6 months from baseline
Population: A total of 140 participants were randomized, with a final completion for this outcome of 75 individuals (56%)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cooling Gel Pack - Venous Leg Ulcer | Differences in Step Counts | 17295 Steps |
| Cooling Cotton Pack - Venous Leg Ulcer | Differences in Step Counts | 14234 Steps |
| Cooling Gel Pack - Diabetic Foot Ulcer | Differences in Step Counts | 13232 Steps |
| Cotton Cooling Pack - Diabetic Foot Ulcer | Differences in Step Counts | 15479 Steps |
Primary
Number of Participants With Ulcer Recurrence
Number of recurrent ulcers that develop during the 6 month study period for in participants for 4 groups of patients with previously healed venous leg ulcers receiving the cooling gel pack and cooling cotton pack and those with previously healed diabetic foot ulcers receiving the cooling gel pack or cooling cotton pack.
Time frame: Through study completion at 6 months from baseline
Population: A total of 140 participants were randomized to either the placebo control group (n=57; 34 VLU, 23 DFU) or the intervention (n=60; 35 VLU, 25 DFU), with a final completion of 117 individuals (84%)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cooling Gel Pack - Venous Leg Ulcer | Number of Participants With Ulcer Recurrence | 6 participants |
| Cooling Cotton Pack - Venous Leg Ulcer | Number of Participants With Ulcer Recurrence | 3 participants |
| Cooling Gel Pack - Diabetic Foot Ulcer | Number of Participants With Ulcer Recurrence | 11 participants |
| Cotton Cooling Pack - Diabetic Foot Ulcer | Number of Participants With Ulcer Recurrence | 5 participants |
p-value: 0.09195% CI: [-0.02, 0.3]Chi-squared
Primary
Time Spent in Minutes Engaging in Physical Activities
Mean time spent in minutes engaging in physical activities, reported via accelerometer data, from baseline to post treatment at 6 months end of intervention for the 4 groups.
Time frame: Through study completion at 6 months from baseline
Population: A total of 140 participants were randomized, with a final completion for this outcome of 75 individuals (56%)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cooling Gel Pack - Venous Leg Ulcer | Time Spent in Minutes Engaging in Physical Activities | 1420 Minutes |
| Cooling Cotton Pack - Venous Leg Ulcer | Time Spent in Minutes Engaging in Physical Activities | 2523 Minutes |
| Cooling Gel Pack - Diabetic Foot Ulcer | Time Spent in Minutes Engaging in Physical Activities | 135 Minutes |
| Cotton Cooling Pack - Diabetic Foot Ulcer | Time Spent in Minutes Engaging in Physical Activities | 157 Minutes |
Secondary
Knowledge Questionnaire of Study Instructions
Participants were administered a 12-item (yes/no) questionnaire (test) during instruction at the start of the study, provided by the research personnel to determine comprehension of the protocol and to reinforce study procedures. Score of 12 or 100% was given for all items scoring correctly (1 point per item). Any items for which no was answered, remediation was conducted by study personnel at the time the questionnaire was conducted. Means scores are reported per VLU and DFU cooling pack intervention and VLU and DFU cotton cooling pack control.
Time frame: Baseline after participant enrollment
Population: Of 140 participants, 140 (100%) completed the questionnaire.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cooling Gel Pack - Venous Leg Ulcer | Knowledge Questionnaire of Study Instructions | 11.7 score on a scale |
| Cooling Cotton Pack - Venous Leg Ulcer | Knowledge Questionnaire of Study Instructions | 11.9 score on a scale |
| Cooling Gel Pack - Diabetic Foot Ulcer | Knowledge Questionnaire of Study Instructions | 11.8 score on a scale |
| Cotton Cooling Pack - Diabetic Foot Ulcer | Knowledge Questionnaire of Study Instructions | 11.9 score on a scale |
Secondary
Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness
Patients satisfaction was measured by study personnel a during end of study phone survey with the following questions asked as follows (Yes/No): Were study instructions adequate, was thermometer easy to use, found cooling helpful, would cool skin area if it was proven that cooling prevented reulceration; (Easy/Not Easy): completing logs, performing the cooling treatment. Data are for (Yes/No) as number of participants who reported yes or if (Easy/Not Easy) the number of participants who reported easy.
Time frame: Survey conducted at end of the 6-month study period.
Population: A total of 140 participants were randomized, with a final completion for this outcome of 122 individuals (87%)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cooling Gel Pack - Venous Leg Ulcer | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Cooling Helpful - Yes | 31 count of participants |
| Cooling Gel Pack - Venous Leg Ulcer | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Would Cool if Found to Prevent Re-Ulceration - Yes | 34 count of participants |
| Cooling Gel Pack - Venous Leg Ulcer | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Using Thermometer Easy - Yes | 36 count of participants |
| Cooling Gel Pack - Venous Leg Ulcer | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Completing Logs - Easy | 36 count of participants |
| Cooling Gel Pack - Venous Leg Ulcer | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Performing Cooling -Treatment - Easy | 35 count of participants |
| Cooling Gel Pack - Venous Leg Ulcer | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Study Instructions Adequate - Yes | 36 count of participants |
| Cooling Cotton Pack - Venous Leg Ulcer | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Using Thermometer Easy - Yes | 32 count of participants |
| Cooling Cotton Pack - Venous Leg Ulcer | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Study Instructions Adequate - Yes | 34 count of participants |
| Cooling Cotton Pack - Venous Leg Ulcer | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Completing Logs - Easy | 33 count of participants |
| Cooling Cotton Pack - Venous Leg Ulcer | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Cooling Helpful - Yes | 21 count of participants |
| Cooling Cotton Pack - Venous Leg Ulcer | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Would Cool if Found to Prevent Re-Ulceration - Yes | 33 count of participants |
| Cooling Cotton Pack - Venous Leg Ulcer | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Performing Cooling -Treatment - Easy | 31 count of participants |
| Cooling Gel Pack - Diabetic Foot Ulcer | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Study Instructions Adequate - Yes | 26 count of participants |
| Cooling Gel Pack - Diabetic Foot Ulcer | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Using Thermometer Easy - Yes | 27 count of participants |
| Cooling Gel Pack - Diabetic Foot Ulcer | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Cooling Helpful - Yes | 21 count of participants |
| Cooling Gel Pack - Diabetic Foot Ulcer | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Performing Cooling -Treatment - Easy | 26 count of participants |
| Cooling Gel Pack - Diabetic Foot Ulcer | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Would Cool if Found to Prevent Re-Ulceration - Yes | 24 count of participants |
| Cooling Gel Pack - Diabetic Foot Ulcer | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Completing Logs - Easy | 27 count of participants |
| Cotton Cooling Pack - Diabetic Foot Ulcer | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Would Cool if Found to Prevent Re-Ulceration - Yes | 25 count of participants |
| Cotton Cooling Pack - Diabetic Foot Ulcer | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Study Instructions Adequate - Yes | 25 count of participants |
| Cotton Cooling Pack - Diabetic Foot Ulcer | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Using Thermometer Easy - Yes | 25 count of participants |
| Cotton Cooling Pack - Diabetic Foot Ulcer | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Completing Logs - Easy | 25 count of participants |
| Cotton Cooling Pack - Diabetic Foot Ulcer | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Performing Cooling -Treatment - Easy | 24 count of participants |
| Cotton Cooling Pack - Diabetic Foot Ulcer | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness | Cooling Helpful - Yes | 18 count of participants |
Secondary
Participant Adherence to the Study Protocol
Using study data logs, appropriate use of the thermometer and cooling pack was measured by the number of participants who adhered to the protocol for taking the temperature of the skin over the healed venous leg or diabetic foot ulcer. Adherence was defined as: the number of participants who were at least 80% adherent to taking their temperatures with the infrared thermometer each morning and the number of participants who were at least 80% adherent to performing the intervention every other day = 3 times times per week during the 6-month study period.
Time frame: Daily measures starting at baseline for temperature and every other day cooling application during the 6-month study period.
Population: This outcome measured ALL participants in one group, rather than across arms, for adherence to temperature and use of cooling pack.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cooling Gel Pack - Venous Leg Ulcer | Participant Adherence to the Study Protocol | Temperature | 106 Participants |
| Cooling Gel Pack - Venous Leg Ulcer | Participant Adherence to the Study Protocol | Cooling | 82 Participants |