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

NCT05076955 | Unknown Early Phase 1 DMC

• 1 other identifier: 2021-UMC014
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Healing Rate

  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.

  12 weeks

Secondary Outcomes (1)

• Wound Closure

  Until the wound is closed up to 12 weeks

Study Arms (1)

Treatment of Diabetic Foot Ulcer

EXPERIMENTAL

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

Interventions

vancomycin-tobramycin-itraconazole DRUG

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 of Diabetic Foot Ulcer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead
• Keystone Pharmacy: collaborator

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

RECRUITING

Related Publications (2)

• Lipsky BA, Berendt AR, Cornia PB, Pile JC, Peters EJ, Armstrong DG, Deery HG, Embil JM, Joseph WS, Karchmer AW, Pinzur MS, Senneville E; Infectious Diseases Society of America. 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis. 2012 Jun;54(12):e132-73. doi: 10.1093/cid/cis346.

  PMID: 22619242 BACKGROUND

• Everett E, Mathioudakis N. Update on management of diabetic foot ulcers. Ann N Y Acad Sci. 2018 Jan;1411(1):153-165. doi: 10.1111/nyas.13569.

  PMID: 29377202 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Laura R Vick, MD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura R Vick, MD

CONTACT

601-278-6213; lvick@umc.edu

Kirby Orme, MD

CONTACT

601-984-5080; korme@umc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants receive the same intervention.

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 13, 2021
• Study Start: March 31, 2021
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: At the end of the study for a period of 6 months or until publication.

Locations

US (1)