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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.
Full 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:
Should healing not occur within 6 months or the wound progress, the patient will be referred for evaluation of possible vascular involvement.
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Volunteers
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
Loss of sensation on forefoot using monofilament
Wound or callus on only 1 foot
Wound Classification - Wagner Grade 1, non-infected
Exclusion criteria
Diagnoses with unpredictable trajectory or healing ability, i.e.
Previous lower extremity amputation
Charcot foot
Evidence of circulatory compromise
Primary purpose
Allocation
Interventional model
Masking
0 participants in 6 patient groups
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Data sourced from clinicaltrials.gov
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