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

Sponsor

University of Mississippi Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05076955

Collaborator

Keystone Pharmacy (Other)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Ulcer	Drug: vancomycin-tobramycin-itraconazole	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

All participants receive the same intervention.All participants receive the same intervention.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 31, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment of Diabetic Foot Ulcer 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.	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.

Arm

Intervention/Treatment

Experimental: Treatment of Diabetic Foot Ulcer

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.

Drug: vancomycin-tobramycin-itraconazole

Outcome Measures

Primary Outcome Measures

Healing Rate [12 weeks]
We will be looking at measurements of the wound at the start of the study and at each study visit until the wound is healed, or the study has ended. The wounds are measured with a ruler by the provider seeing the patient at the time of the visit in centimeters. The wounds are also photographed with a ruler in the photograph for size.

Secondary Outcome Measures

Wound Closure [Until the wound is closed up to 12 weeks]
Assessing how many patients wounds closed during the study and the time in weeks it took for the patient to close their wound.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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