Diabetic Foot Ulcers, Wound
Conditions
Keywords
Diabetic Foot Ulcer, Topical Oxygen Therapy, Medicaid Recipients, Standard of Care, Diabetic Wounds
Brief summary
This is a pilot study which is intended to collect data to calculate an adequate sample size for a larger registered clinical trial. Eleven subjects were enrolled at The Ohio State University; we intend to enroll 29 more subjects at Indiana University. Due to the small sample size this study will primarily be a feasibility study that will attempt to measure and evaluate differences in the relative theoretical costs of the intervention of topical oxygen therapy on this population and subsequently compare outcomes in areas such as overall health improvements and cost effectiveness.
Detailed description
There are a total of 5 study visits including the initial baseline visit were they will be randomized into one of the 2 groups (comparison or treatment). At the baseline visit the following will be collected; history of the patient, physical examination of the patient including:, digital imaging of the diabetic foot ulcer (DFU) or chronic wound that is input into the WoundMatrix™ software, and the patient will be asked to complete a quality of life questionnaire. Patients will be provided with education regarding diabetes, footwear, and wound care. They will also be given a diary to log their treatments. Patients will return for study visits 2-5 on weeks 4, 8, 12, 16. At study visit 2-5 the research staff will collect digital imaging of the ulcer, review medication, collect previous diary and distribute a new one, and note any wound or health complications. At study visits 1 and 5, the patient will be asked to complete the quality of life questionnaire. These visits will be correlated with their regular scheduled visit at the CWC. If their wound heals before the end of the study, they will be asked to return for study visit 5 (week 16). The patient will complete the at home treatments, including the 90 minute treatment, 4 consecutive days a week, 3 day of no treatment). Study personnel will provide supplies, teach, and give support for the TO device. The study personnel will contact the subject weekly to give support for the treatments. Participation in this study is expected to add no additional risk to the patient. There is a low risk of local irritation of the skin from application of the Topical Oxygen device for those in the Topical Oxygen Therapy group. This issue is anticipated in the protocol, which specifies appropriate treatment modifications and discontinuation of Topical Oxygen, if it does not improve. If this problem occurs, is expected to be self-limited and of minor significance. Oxygen, although not combustible itself, supports combustion of other flammable materials. The use of oxygen in this protocol is essentially equivalent to that supplied by nasal cannula to patients in hospital or at home. To minimize the risk of fire, the investigators will strictly enforce a 'no smoking' and 'no open flame' policy in any room where Topical Oxygen is utilized. Treatment facilities will comply with local fire ordinances and study personnel will be familiar with fire safety protocols of each facility. Participants may or may not experience directly benefit from participating in this study. The disease state is highly morbid and typically involves prolonged medical care and multiple surgical procedures. Participants may experience improved healing of their wound as a result of their participation in this study, but there is no guarantee of this. Patients enrolled in the study may also benefit from the close follow-up with study staff and compliance with wound treatment. In addition, the information learned from this research study may lead to a better understanding of diabetic wounds and how they heal, which could lead to better treatment options for patients with diabetic wounds in the future. The application of topical oxygen to diabetic wounds has the potential to dramatically impact the effectiveness of wound healing and to therefore improve limb salvage, decrease infection rates and mortality, and generally improve the quality of life of study participants receiving topical oxygen as well as the general population if efficacy is proved.
Interventions
DEVICETopical Oxygen Chamber for Extremities
Surrounds a limb and applies oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * Able to give informed consent, willing and able to visit the hospital and CWC for regular treatment and follow-up visits. * Diabetic * -Chronic wound OR Foot Ulcer: * Ulcer present by history ≥ 4 weeks at time of enrollment * Compliant with standard wound care regimen * IF foot wound, Wagner grade 1 and 2, OR Wagner grade 3 * Ulcer size: 0.6 cm2 to 20 cm2 and has not decreased in size by more than 30% in previous 2 weeks of the enrollment visit * Adequate circulatory status, as evidenced by any of the following: * Ankle Brachial Index (ABI) ≥0.7 - ≥ 1.20 * If ABI non-compressible (ABI \>1.2), then toe brachial Index (TBI)\>0.5 * SPP \> 30mmHg * TcOM \> 30mmHg * At least 4 weeks since revascularization procedure, if one has been performed * Able to complete Topical Oxygen Therapy 4 day/week for 16 weeks (must be able to remove existing wound dressing and apply TO2 Boot/treatment, and then re-dress wound)
Exclusion criteria
* Ulcer in area of radiation treatment. * Active malignancy at site of ulcer * Current treatment with wound VAC or weekly compression dressing * Untreated infection at site of ulcer (i.e. cellulitis or osteomyelitis) * If acute osteomyelitis has been diagnosed, patient may be enrolled only after the infection has been controlled. Including: 1. Debridement of infected bone if necessary 2. Patient has received at least 2 weeks of appropriate antibiotics * ABI \< 0.7 or \> 1.2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wound Closure | baseline and 16 weeks | Wound healing rates at 16 weeks of Topical Oxygen Therapy or Standard of Care |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Amputations | 16 weeks | Amputations rates 16 weeks of Topical Oxygen Therapy or Standard of Care |
| Complication Rate | 16 weeks | Complication rates (infection) at 16 weeks of Topical Oxygen Therapy or Standard of Care |
| Cost of Care | 16 weeks | Post-test health expenditures at 16 weeks of Topical Oxygen Therapy or Standard of Care |
| Quality of Life for Subjects- SF-36 | 16 weeks | QoL data at 16 weeks of Topical Oxygen Therapy or Standard of Care. A cumulative score was calculated based on the QoL responses: Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care With Topical Oxygen Treatment patients who have a chronic wound, will receive their receive standard treatment plus Topical Oxygen Therapy (Topical Oxygen Chamber for Extremities).
Topical Oxygen Chamber for Extremities: Surrounds a limb and applies oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers | 1 |
| Standard of Care Only patients that have a chronic wound will receive only their standard of care treatment. | 1 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Standard of Care Only | Total | Standard of Care With Topical Oxygen Treatment |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 1 Participants |
| Age, Continuous | 63 years | 53.5 years | 44 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 1 participants | 2 participants | 1 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
Change in Wound Closure
Wound healing rates at 16 weeks of Topical Oxygen Therapy or Standard of Care
Time frame: baseline and 16 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care With Topical Oxygen Treatment | Change in Wound Closure | 3.3 cm2 |
| Standard of Care Only | Change in Wound Closure | 0.00 cm2 |
Secondary
Complication Rate
Complication rates (infection) at 16 weeks of Topical Oxygen Therapy or Standard of Care
Time frame: 16 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care With Topical Oxygen Treatment | Complication Rate | 1 Participants |
| Standard of Care Only | Complication Rate | 1 Participants |
Secondary
Cost of Care
Post-test health expenditures at 16 weeks of Topical Oxygen Therapy or Standard of Care
Time frame: 16 weeks
Population: no data could be collected on the cost of measure
Secondary
Quality of Life for Subjects- SF-36
QoL data at 16 weeks of Topical Oxygen Therapy or Standard of Care. A cumulative score was calculated based on the QoL responses: Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
Time frame: 16 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care With Topical Oxygen Treatment | Quality of Life for Subjects- SF-36 | 38.9 percent of total response |
| Standard of Care Only | Quality of Life for Subjects- SF-36 | 51.5 percent of total response |
Secondary
Rate of Amputations
Amputations rates 16 weeks of Topical Oxygen Therapy or Standard of Care
Time frame: 16 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care With Topical Oxygen Treatment | Rate of Amputations | 0 Participants |
| Standard of Care Only | Rate of Amputations | 0 Participants |