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

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05076955
• Other study ID #: 2021-UMC014
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 31, 2021
• Est. completion date: December 2022

Study information

• Verified date: September 2021
• Source: University of Mississippi Medical Center
• Contact: Laura R Vick, MD
• Phone: 601-278-6213
• Email: lvick[@]umc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
University of Mississippi Medical Center	Keystone Pharmacy

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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