A Randomized Controlled Multicenter Clinical Trial Evaluating Dehydrated Human Amnion Membrane (dhAM) and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers

Axolotl Biologix1 site in 1 country100 target enrollmentSeptember 23, 2024

ConditionsDiabetic Foot Ulcer Foot Foot Ulcer Diabetic Foot Ulcer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetic Foot
Sponsor: Axolotl Biologix
Enrollment: 100
Locations: 1
Primary Endpoint: Efficacy of dhAM + SOC vs SOC
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy of dehydrated human amnion membrane (dhAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).

Detailed Description

AXOCAMP is a multi-center randomized controlled clinical trial. The study will evaluate the efficacy of dehydrated human amnion membrane (dhAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).

Registry

clinicaltrials.gov

Start Date

September 23, 2024

End Date

October 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Axolotl Biologix

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must be at least 18 years of age or older.
•Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
•At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 5.0 cm2 measured post debridement.
•The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
•The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
•The target ulcer must be Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.
•The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
•ABI ≥ 0.7 and ≤ 1.3;
•TCOM ≥ 40 mmHg;
•PVR: biphasic.

Exclusion Criteria

•A subject known to have a life expectancy of \< 6 months is excluded.
•The subject is excluded if the target ulcer is not secondary to diabetes.
•If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
•If there is evidence of osteomyelitis complicating the target ulcer, the subject is excluded.
•A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
•A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
•The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
•A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
•The subject is excluded if the surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). Photographic planimetry is not required for measurements taken during the historical run-in period (e.g. calculating surface area using length x width is acceptable).
•The subject is excluded if the surface area measurement of the Target ulcer decreases by 20% or more during the 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1/randomization visit, during which time the subject received SOC.

Outcomes

Primary Outcomes

Efficacy of dhAM + SOC vs SOC

Time Frame: 1-12 Weeks

To determine the efficacy of dhAM plus SOC versus SOC alone in achieving complete closure of nonhealing diabetic foot ulcers over 12 weeks.

Secondary Outcomes

Percent area reduction(1-12 weeks)
Adverse events(1-12 Weeks)
Determine improvement in quality of life using Wound Quality of Life questionnaire(1-12 weeks)
Time to closure for the target ulcer(1-12 weeks)
Determine improvement in quality of life using Forgotten Wound Score questionnaire(1-12 weeks)