NCT05076955

Evaluating the Healing of Diabetic Foot Ulcers With Compounded Anti-Infective Irrigation Therapy

Evaluating the Healing of Diabetic Foot Ulcers With Compounded Anti-Infective Irrigation

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Mississippi Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DRUG	vancomycin-tobramycin-itraconazole	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. This is an irrigating foot bath with a compounded medication of vancomycin-tobramycin-itraconazole. This medication with combined 3/4 gallon of water. Participant will soak foot in solution for 10 minutes per day. Daily until wound is healed for a minimum of 4 weeks and a maximum of 3 months.

Timeline

• Start date: 2021-03-31
• Primary completion: 2022-08-01
• Completion: 2022-12-01
• First posted: 2021-10-13
• Last updated: 2021-10-13

Locations

1 site across 1 country: United States