NCT05076955|UnknownEarly Phase 1DMC
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Sponsor study identifier
interventional
100
1 country
1
Study Start
March 31, 2021
Actual (reported)Primary Completion
August 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 31, 2021
Actual (reported)September 30, 2021
Actual (reported)October 13, 2021
Actual (reported)August 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Wound Closure
Until the wound is closed up to 12 weeks
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
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.
Laura R Vick, MD
University of Mississippi Medical Center
First Submitted
September 30, 2021
First Posted
October 13, 2021
Study Start
March 31, 2021
Actual (reported)Primary Completion
August 2022
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 13, 2021
Record last verified: 2021-09
We plan to share deidentified data that is collected in the study in full. All IPD that will result in publication.
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Source: ClinicalTrials.gov.
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