Diabetic Foot, Diabetic Foot Ulcer, Foot Ulcer, Ulcer Foot
Conditions
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
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).
Interventions
OTHERStandard of Care
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHERAxolotl DualGraft + SOC
Participants will receive weekly applications of Axolotl DualGraft and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Sponsors
SerenaGroup, Inc.
Axolotl Biologix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of dhAM + SOC vs SOC | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to closure for the target ulcer | 1-12 weeks | To determine the proportion of ulcers that heal over 12 weeks for dhAM plus SOC versus SOC alone (Time to closure). |
| Percent area reduction | 1-12 weeks | To determine the percent area reduction (PAR) of the ulcer over the 12-week treatment period. |
| Adverse events | 1-12 Weeks | To demonstrate a reduction in adverse events in subjects receiving dhAM plus SOC versus SOC alone. |
| Determine improvement in quality of life using Wound Quality of Life questionnaire | 1-12 weeks | Quality of Life is assessed using the Wound Quality of Life (wQOL) checklist at TV1, TV3, TV7, TV11, and TV12. This assessment will be used to compare patients receiving dhAM + SOC vs SOC. |
| Determine improvement in quality of life using Forgotten Wound Score questionnaire | 1-12 weeks | Quality of life is assessed using the Forgotten Wound Score (FWS) at TV1, TV3, TV7, TV11, and TV12. This assessment will be used to compare patients receiving dhAM + SOC vs SOC. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of ulcers that heal in patients 65 years and older | 1-12 weeks | To determine the proportion of ulcers that heal in patients 65 years or older for dhAM plus SOC versus SOC alone. |
| Determine the effect of chronic inhibitory bacterial load (CIBL) on wound closure | 1-12 weeks | To determine the effect of chronic inhibitory bacterial load (CIBL) as assessed by fluorescence imaging on wound closure. Fluorescent imaging will be assessed at TV1, TV4, TV8, and TV12. |
Countries
United States
Contacts
Primary ContactBennett M Rogers
Backup ContactThomas Serena, MD
Outcome results
None listed