Clinical trial NCT05076955: Evaluating the Healing of Diabetic Foot Ulcers With Compounded Anti-Infective Irrigation Therapy
Official title: Evaluating the Healing of Diabetic Foot Ulcers With Compounded Anti-Infective Irrigation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Diabetic Foot Ulcer
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: Keystone Pharmacy
First posted: 2021-10-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants receive the same intervention.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Healing Rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Wound Closure
timeFrame: Until the wound is closed up to 12 weeks
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Laura R Vick, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.