Diabetic Foot Ulcers
Conditions
Keywords
diabetes, foot ulcers, off-loading, collagen, Wagner 1
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.
Interventions
OTHERtype of footwear
comparison of results between post-op shoe, air boot which the patient can remove ad lib and air boot whose removal can be monitored
OTHERcollagen dressing with and without silver
silver-impregnated collagen dressing will be used for 2 weeks, then plain collagen dressing will be used for the remainder of the 6 months
Sponsors
Harris County Hospital District
Baylor College of Medicine
The University of Texas Health Science Center, Houston
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| decrease in size of wound | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| non-healing wound | 6 months or less |
Countries
United States
Outcome results
None listed