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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Drug: vancomycin-tobramycin-itraconazole

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Laura R Vick, MD; Phone Number: 601-278-6213; Email: lvick@umc.edu
• Study Contact Backup: Name: Kirby Orme, MD; Phone Number: 601-984-5080; Email: korme@umc.edu

Study Locations

• United States
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Recruiting
      • University of Mississippi Medical Center
      • Contact: Laura R Vick, MD; Phone Number: 601-278-6213; Email: lvick@umc.edu
      • Contact: Kirby Orme, MD; Phone Number: 601-984-5080; Email: korme@umc.edu
      • Sub-Investigator: Gloria Jaques, NP
      • Sub-Investigator: Kirby Orme, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Mississippi Medical Center
• Collaborators: Keystone Pharmacy
• Investigators: Principal Investigator: Laura R Vick, MD, University of Mississippi Medical Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: September 30, 2021
• First Submitted That Met QC Criteria: September 30, 2021
• First Posted (Actual): October 13, 2021

Study Record Updates

• Last Update Posted (Actual): October 13, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Vancomycin; Itraconazole; Tobramycin
• Other Study ID Numbers: 2021-UMC014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: We plan to share deidentified data that is collected in the study in full. All IPD that will result in publication.
• IPD Sharing Time Frame: At the end of the study for a period of 6 months or until publication.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No