Diabetic Foot, Diabetic Foot Ulcer, Foot Ulcer, Foot Ulcer, Diabetic, Foot Ulcer Due to Type 2 Diabetes Mellitus
Conditions
Keywords
Ulcer, Foot Ulcer, Diabetic Foot Ulcer, Foot
Brief summary
This study will evaluate two human amnion/chorion membrane (ppLHACM) products and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).
Detailed description
The CAMPAIGN trial is evaluating PURION Processed Lyophilized Human Amnion/Chorion Membrane (ppLHACM) and Standard of Care versus Standard of Care alone in the treatment of Nonhealing Diabetic Foot Ulcers. The study will evaluate two products, EPIEFFECT® and EPIXPRESS™, which are both ppLHACMs.
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.
OTHEREPIEFFECT
Participants will receive weekly applications of EPIEFFECT and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first
OTHEREPIXPRESS
Participants will receive weekly applications of EPIXPRESS and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first
Sponsors
SerenaGroup, Inc.
MiMedx Group, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
CAMPAIGN uses a Prospective Modified Platform Multicenter Randomized Controlled Clinical Trial design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 18 years of age or older. 2. 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 cm\^2 and a maximum surface area of 5.0 cm\^2 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 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. 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. Ankle-Brachial Index (ABI) between 0.7 and ≤ 1.3; 2. Toe-Brachial Index (TBI) ≥ 0.6; 3. Transcutaneous Oxygen Measurement (TCOM) ≥ 40 mmHg; 4. Pulse Volume Resistance (PVR): biphasic. 8. If the potential 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. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment. 10. The potential subject must consent to using the prescribed offloading method for the duration of the study. 11. The potential subject must agree to attend the weekly study visits required by the protocol. 12. The potential subject must be willing and able to participate in the informed consent process.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of target ulcers achieving wound closure | 1 - 12 weeks | The percentage of target ulcers achieving complete wound closure in 12 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of wound closure area | 1 - 12 weeks | Percentage wound area reduction from treatment visit (TV)-1 to TV-13 measured weekly with digital photographic planimetry and physical examination |
| Adverse Events | 1 - 12 weeks | Number of adverse events will be evaluated weekly |
| Change in Pain in Target Ulcer | 1 - 12 weeks | Change in pain in the target ulcer assessed using the Pain, Enjoyment of Life and General Activity (PEG) scale |
| Change in Quality of Life | 1 - 12 weeks | Change in quality-of-life using the Wound Quality of Life (wQOL) questionnaire |
Countries
United States
Contacts
Primary ContactBrittany Bonafide
Backup ContactThomas Serena, MD
Outcome results
None listed