DFU, Diabetic Foot, Diabetic Foot Ulcer, Foot Ulcer, Ulcer Foot
Conditions
Brief summary
A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care versus Standard of Care alone in the management of Nonhealing Diabetic Foot Ulcers
Detailed description
XCAMP is a multi-center randomized controlled clinical trial. The study will evaluate the efficacy of a single layer amniotic membrane (SLAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs). XWRAP® is an allograft membrane derived from human amniotic tissue. Designed to act as a protective barrier, it is effective for DFUs, venous leg ulcers (VLUs), and pressure ulcers \[13\]. The processing of XWRAP® is designed to preserve the structural integrity of the amniotic epithelial membrane \[13\]. The product is screened and tested in a Clinical Laboratory Improvement Amendment (CLIA) certified lab that meets or exceeds AATB criteria \[13\].
Interventions
OTHERSLAM + SOC
Weekly Treatment visits for 12 weeks begin at day 0. SLAM applications with SOC until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHERSOC
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.
Sponsors
SerenaGroup, Inc.
Applied Biologics, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study will evaluate the efficacy of a single layer amniotic membrane (SLAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects must be at least 18 years of age or older, 2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus. 3. At randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement. 4. 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. 5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus. 6. The target ulcer must be Wager 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. 7. 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. 8. 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. 9. The subject must consent to using the prescribed off-loading method for the duration of the study. 10. The subject must agree to attend the weekly study visits required by the protocol. 11. The subject must be willing and able to participate in the informed consent process.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of target ulcers achieving complete wound closure in 12 weeks. | 1-12 Weeks | The percentage of target ulcers achieving complete wound closure in 12 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life | 1-12 weeks | Change in quality-of-life using the wQOL(Wound Quality of Life) questionnaire \[Time Frame: TV-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or Final Visit\]. |
| The time to heal for target ulcers. | 1-12 weeks | Time to closure will be determined for each treatment group and compared to SOC. |
| Wound Area Reduction | 1-12 weeks | Percentage wound area reduction from TV-1 to TV-13 measured weekly with digital photographic planimetry, using MolecuLight Imaging Device, and physical examination. |
| Adverse Events | 1-14 Weeks | Incidence of adverse events will be evaluated weekly from TV-1 to the healing confirmation visit (HCV). |
| Change in pain in the target ulcer | 1-12 weeks | Change in pain in the target ulcer assessed using the PEG (pain, enjoyment in life, and general pain) scale. \[Time Frame: TV-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or Final Visit\]. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of target ulcers achieving complete wound closure | 1-12 weeks | Percentage of target ulcers achieving complete wound closure in 12 weeks for subjects 65 years of age or older. |
| Changes in chronic inhibitory bacterial load | 1-14 weeks | Changes in chronic inhibitory bacterial load (CIBL) measured using fluorescence imaging. |
Countries
United States
Contacts
Primary ContactBennett Rogers
Backup ContactThomas Serena
Outcome results
None listed