Clinical trial NCT06550596: Dehydrated Human Amnion Membrane and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot
Ulcer Foot
Foot Ulcer
Diabetic Foot Ulcer
Keywords: Cellular, Acellular, Matrix-like Product (CAMP)
Dehydrated Human Amnion Membrane (dhAM)
Vascular Diseases
Leg Ulcer
Ulcer leg
Skin Ulcer
Diabetes Complications
Diabetes Mellitus
Diabetic Neuropathies
Foot Diseases
Diabetic Foot
Foot Ulcer
Ulcer
Lead sponsor: Axolotl Biologix
Sponsor class: INDUSTRY
Collaborators: name: SerenaGroup, Inc.
First posted: 2024-08-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: AXOLCAMP is a multi-center, open label, randomized controlled trial to determine the efficacy of dhAM plus SOC versus SOC alone in achieving complete closure of nonhealing diabetic foot ulcers.

over 12 weeks.
Primary purpose: TREATMENT

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).

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:

  1. ABI ≥ 0.7 and ≤ 1.3;
  2. TBI ≥ 0.6;
  3. TCOM ≥ 40 mmHg;
  4. PVR: biphasic.
* If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
* The subject must consent to using the prescribed offloading method for the duration of the study.
* The subject must agree to attend the weekly study visits required by the protocol.
* The subject must be willing and able to participate in the informed consent process.

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.
* A subject is excluded if they are malnourished: a score of less than 17 on the Mini Nutritional Assessment (MNA).
* A Subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.
* Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
* A potential subject with end stage renal disease requiring dialysis is excluded.
* A subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments is excluded.
* A Subject treated with hyperbaric oxygen therapy or a Cellular Acellular, or Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit is excluded.

Primary outcomes:
measure: Efficacy of dhAM + SOC vs SOC
timeFrame: 1-12 Weeks
Secondary outcomes:
measure: Time to closure for the target ulcer
timeFrame: 1-12 weeks
measure: Percent area reduction
timeFrame: 1-12 weeks
measure: Adverse events
timeFrame: 1-12 Weeks
measure: Determine improvement in quality of life using Wound Quality of Life questionnaire
timeFrame: 1-12 weeks
measure: Determine improvement in quality of life using Forgotten Wound Score questionnaire
timeFrame: 1-12 weeks
Other outcomes:
measure: Proportion of ulcers that heal in patients 65 years and older
timeFrame: 1-12 weeks
measure: Determine the effect of chronic inhibitory bacterial load (CIBL) on wound closure
timeFrame: 1-12 weeks
Locations:
city: Thousand Oaks
country: United States
facility: Performance Foot and Ankle Specialists
state: California
Study officials:
References: