Evaluating the Healing of Diabetic Foot Ulcers With Compounded Anti-Infective Irrigation Therapy
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Diabetic foot ulcers (DFUs) are a frequent clinical problem observed in diabetic patients.
Properly managed, most can be cured, but many patients needlessly undergo amputations because
of improper diagnostic and therapeutic approaches. The purpose of this study is to evaluate
the effectiveness of a compounded, anti-infective irrigation therapy to increase the healing
rates of diabetic foot ulcers and thereby provide a new therapeutic option for health care
providers treating high-risk patients with DFUs regardless if secondary fungal infections are
present.
Participants diagnosed with diabetes type 1 or 2 and with a documented open diabetic foot
ulcer/wound with or without a secondary fungal infection will be included in this
prospective, active intervention pilot study. Healing rates will be evaluated every two weeks
following the initiation of study therapy up to three months. Participants with diabetic foot
ulcers will be treated with a compounded, anti-infective irrigation therapy daily until
closure of the ulcer or up to a maximum of 3 months. Participants will be asked to return to
clinic every two - four weeks for assessment of the ulcer and compliance with treatment.
A sample size of approximately 100 patients is estimated to have 90% power to detect 15%
improvement in ulcer healing rates to 45% and 35% compared to historical benchmarks of
approximately 30% for ulcers of <6 months duration and 20% for ulcers ≥6 months duration
and/or prior treatment failure, respectively.