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

University of Mississippi

Status and phase: Unknown; Early Phase 1

Conditions: Diabetic Foot Ulcer

Treatments: Drug: vancomycin-tobramycin-itraconazole

Study type: Interventional

Funder types: Other

Identifiers

NCT05076955

2021-UMC014

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 or Type 2 diabetes mellitus
• An open DFU / wound of any size (including those requiring debridement in operation room or clinic setting) with or without a secondary fungal infection
• ≥ 18 years of age
• Treatment naïve or treatment failure with oral antibiotics to current wound infection

Exclusion criteria

• Patients who present with untreated or on active-treatment for osteomyelitis, exposed bone, or have a life-threatening need of immediate surgery.
• Patients who are allergic to any components of the investigated product.
• Patients who have ≥ 15 shoe size
• Patients who have received IV antibiotics within the past 30 days
• Patients with HgbA1C > 14
• Patients on active cancer treatment
• Patients needing re-vascularization of the affected area but did not receive treatment.
• Patients diagnosed with HIV/AIDs
• Patients unable or unwilling to obtain and wear off-loading footwear

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

Treatment of Diabetic Foot Ulcer

Experimental group

Description:

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.

Treatment:

Drug: vancomycin-tobramycin-itraconazole