Diabetes
Conditions
Keywords
diabetes, foot ulcer prevention, therapeutic stockings
Brief summary
1. To evaluate the efficacy of a therapeutic stockings (Protective Foot Care stockings, PFC) in reducing the incidence of diabetic foot pathology among high-risk patients. 2. To evaluate perceived health-related quality of life as compared to guideline directed usual care in patients who use the PFC stockings.
Detailed description
We will identify a cohort of high-risk diabetic patients and assign them to two treatment groups. We plan to enroll patients from three sites: Scott and White Hospital in Temple Texas, Manchester Royal Infirmary, UK , and Trinity College Dublin at St James Hospital.. The two treatment arms will involve a Standard Therapy Group, and a Stocking Therapy Group. The Stocking Therapy group will use the special padded and friction reducing stockings in their standard shoes during the course of the study. Patient enrollment will occur over a one-year period. All patients will be followed for 30 months. The Standard Therapy Group will receive therapeutic shoes, standard insoles, patient education and regular foot evaluations by a physician every 10-12 weeks. The Stocking Therapy Group will receive standard therapy as described above but use the special stockings instead of their usual hose. The investigator at each site will be blinded regarding the treatment.
Interventions
BEHAVIORALStandard therapy
Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.
DEVICEPFC Stockings
A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women 18 years old or older * Diagnosis of Diabetes Mellitus\* * History of diabetes related foot ulceration Spanish-speaking subjects will be eligible to participate.
Exclusion criteria
* Active Charcot Arthropathy * Gangrene, active infection * Midfoot or higher level amputation * Alcohol or substance abuse within 6 months * Unreliable, unwilling or unable to comprehend informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Developed Foot Ulcer During Study Time Frame | 30 months | An ulceration will be defined as full thickness loss of epidermis and dermis or involvement of deeper structures. |
Countries
United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PFC Stockings The stocking therapy group will be given PFC shear reducing stockings to wear.
PFC Stockings: A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases. | 195 |
| Standard Therapy Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.
Standard therapy: Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear. | 186 |
| Total | 381 |
Baseline characteristics
| Characteristic | Total | PFC Stockings | Standard Therapy |
|---|---|---|---|
| Age, Continuous | 53.72 years STANDARD_DEVIATION 9.64 | 52.06 years STANDARD_DEVIATION 11.14 | 56.08 years STANDARD_DEVIATION 6.76 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 98 Participants | 56 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 269 Participants | 133 Participants | 136 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 14 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 19 Participants | 6 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 40 Participants | 17 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) White | 310 Participants | 166 Participants | 144 Participants |
| Region of Enrollment United Kingdom | 147 participants | 70 participants | 77 participants |
| Region of Enrollment United States | 234 participants | 125 participants | 109 participants |
| Sex: Female, Male Female | 94 Participants | 51 Participants | 43 Participants |
| Sex: Female, Male Male | 287 Participants | 144 Participants | 143 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 195 | 7 / 186 |
| other Total, other adverse events | 99 / 195 | 99 / 186 |
| serious Total, serious adverse events | 30 / 195 | 16 / 186 |
Outcome results
Primary
Number of Participants Who Developed Foot Ulcer During Study Time Frame
An ulceration will be defined as full thickness loss of epidermis and dermis or involvement of deeper structures.
Time frame: 30 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PFC Stockings | Number of Participants Who Developed Foot Ulcer During Study Time Frame | 76 Participants |
| Standard Therapy | Number of Participants Who Developed Foot Ulcer During Study Time Frame | 82 Participants |