Developing a Diabetic Foot Ulcer Protocol
- Conditions
- Diabetic Foot Ulcers
- Interventions
- Other: type of footwearOther: collagen dressing with and without silver
- Registration Number
- NCT01068171
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
-
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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description boot, plain dressing type of footwear air boot with occlusive dressing monitored boot with collagen collagen dressing with and without silver air boot with retention strap to monitor whether boot is removed with collagen dressing shoe, plain dressing type of footwear post-op shoe with plain occlusive dressing shoe, collagen collagen dressing with and without silver post-op shoe with collagen dressing boot, collagen collagen dressing with and without silver air boot with collagen dressing monitored air boot, plain dressing type of footwear air boot with retention strap to monitor whether boot is removed with occlusive dressing
- Primary Outcome Measures
Name Time Method decrease in size of wound 6 months
- Secondary Outcome Measures
Name Time Method non-healing wound 6 months or less
Trial Locations
- Locations (1)
Harris County Hospital District Community Health
🇺🇸Houston, Texas, United States