Developing a Diabetic Foot Ulcer Protocol

Study Overview
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Brief Summary
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The purpose of this study is to determine which treatment, over 6 months, will promote healing of diabetic foot ulcers that are not infected in the most efficient, cost-effective way.

Detailed Description
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This pilot study will be conducted in Harris County Hospital District (HCHD) Community Health Centers and Wound Care Clinics. The study will use random assignment of patients who meet inclusion criteria to: postoperative shoe with or without collagen; removable Air-boot with or without collagen; or monitored Air-boot with or without collagen. All treatment is standard of care. Enrollment will occur at a clinic appointment. During the consent appointment, follow-up will be scheduled. Patients whose wound meets study criteria will be approached by a Podiatrist or therapist during a wound care visit. An A1c will be obtained, if not done within the past 3 months. A convenience sample will be drawn from people with diabetes, aged 18 or more, who meet inclusion criteria. Frequency of visits will be: patients with monitored Air-boot: weekly all others: every 2 weeks At each visit there will be a dressing change, wound assessment and review of how many times shoe/boot was removed or not used during the preceding 1 or 2 weeks. Should healing not occur within 6 months or the wound progress, the patient will be referred for evaluation of possible vascular involvement.

Official Title
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Developing a Diabetic Foot Ulcer Protocol in a Multi-ethnic, Underserved Population

Conditions
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Diabetic Foot Ulcers

Intervention / Treatment
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* Other: type of footwear
* Other: collagen dressing with and without silver


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult - over 18 years of age Diabetes with an A1c of less than or equal to 9% - if no A1c result is available within the past 3 months, one will be drawn to qualify the patient for the study No evidence of circulatory compromise Posterior tibial or pedal pulse present on palpation No pallor on elevation No dependent rubor Loss of sensation on forefoot using monofilament Wound or callus on only 1 foot Wound Classification - Wagner Grade 1, non-infected Ulcer present for 1 - 3 months Ulcer of forefoot only No previous ulcer of that foot or amputation of either extremity Wound size < 1 diameter Wound bed pink Exclusion Criteria: Diagnoses with unpredictable trajectory or healing ability, i.e. Psychiatric disorders Cancer ESRD not eligible for dialysis HIV Previous lower extremity amputation Charcot foot Evidence of circulatory compromise Absence of pulses Decreased capillary refill (> 3 seconds) Trophic skin changes - shiny, hairless toes Ankle Brachial Index < 0.8

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: shoe, plain dressing<br>post-op shoe with plain occlusive dressing | Other: type of footwear<br>* comparison of results between post-op shoe, air boot which the patient can remove ad lib and air boot whose removal can be monitored<br>* Other names: Smith and Nephew Allevyn Foam dressing;|
| Active Comparator: shoe, collagen<br>post-op shoe with collagen dressing | Other: collagen dressing with and without silver<br>* silver-impregnated collagen dressing will be used for 2 weeks, then plain collagen dressing will be used for the remainder of the 6 months<br>* Other names: Smith & Nephew Biostep Ag gressing with Allevyn Foam cover;|
| Active Comparator: boot, plain dressing<br>air boot with occlusive dressing | Other: type of footwear<br>* comparison of results between post-op shoe, air boot which the patient can remove ad lib and air boot whose removal can be monitored<br>* Other names: Smith and Nephew Allevyn Foam dressing;|
| Active Comparator: boot, collagen<br>air boot with collagen dressing | Other: collagen dressing with and without silver<br>* silver-impregnated collagen dressing will be used for 2 weeks, then plain collagen dressing will be used for the remainder of the 6 months<br>* Other names: Smith & Nephew Biostep Ag gressing with Allevyn Foam cover;|
| Active Comparator: monitored air boot, plain dressing<br>air boot with retention strap to monitor whether boot is removed with occlusive dressing | Other: type of footwear<br>* comparison of results between post-op shoe, air boot which the patient can remove ad lib and air boot whose removal can be monitored<br>* Other names: Smith and Nephew Allevyn Foam dressing;|
| Active Comparator: monitored boot with collagen<br>air boot with retention strap to monitor whether boot is removed with collagen dressing | Other: collagen dressing with and without silver<br>* silver-impregnated collagen dressing will be used for 2 weeks, then plain collagen dressing will be used for the remainder of the 6 months<br>* Other names: Smith & Nephew Biostep Ag gressing with Allevyn Foam cover;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease in size of wound |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| non-healing wound |  | 6 months or less | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, foot ulcers, off-loading, collagen, Wagner 1