Cardiovascular Diseases, Diabetes Complications, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetic Angiopathies, Diabetic Foot, Diabetic Neuropathies, Endocrine System Disease, Foot Diseases, Foot Ulcer, Foot Ulcer Unhealed, Glucose Metabolism Disorders, Leg Ulcer, Metabolic Diseases, Pathologic Processes, Skin Diseases, Skin Ulcer, Ulcer, Vascular Diseases
Conditions
Keywords
Human Placental Membrane (HPM), Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU), Cellular, Acellular, and Matrix-like Product (CAMP), Cellular and/or Tissue-Based Product (CTP)
Brief summary
The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) over 12 weeks using a modified platform trial design.
Detailed description
The C5CAMP trial is a multicenter, prospective, randomized controlled clinical trial to evaluate subjects that meet medical necessity criteria for cellular, acellular, and matrix-like products (CAMPs). The study utilizes a prospective modified platform design to evaluate two separate CAMPs, AM/Single and AM/Double in a single trial. The initial plan is to evaluate two CAMPs; however, the modified platform design permits the inclusion of additional CAMPs. This study will evaluate the clinical utility of multiple CAMPs in the closure of diabetic foot ulcers and venous leg ulcers in subjects in comparison to Standard of Care treatment.
Interventions
OTHERStandard of Care - DFU
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.
OTHERAM/Single - DFU
Participants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHERAM/Double - DFU
Participants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHERStandard of Care - VLU
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and compression) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHERAM/Single - VLU
Participants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHERAM/Double - VLU
Participants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Sponsors
SerenaGroup, Inc.
C5 Biomedical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
In addition to the principal investigator's determination of complete closure an independent assessment of the primary endpoint will be performed. Two wound care specialists not associated with the trial (The Reviewers) will review the digital images of ulcers that have healed. They will review the closed visit and the closure confirmation visit. Deidentified digital images taken with the imaging device will be provided to the reviewers. Two reviewers will assess each photograph and be blinded to the arm in the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for DFU: 1. At least 18 years of age or older. 2. Must have diagnosis of type 1 or 2 Diabetes mellitus. 3. At enrollment, subject 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 with the imaging device. 4. Must have a target ulcer that has been present for a minimum of 4 weeks and maximum of 52 weeks of standard of care, prior to screening visit. 5. Target ulcer located on the foot with at least 50% of the ulcer below the malleolus. 6. Target ulcer that is 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. Subject's 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 between 0.7 and \<= 1.3 2. TBI \>= 0.6 3. TCOM \>= 40 mmHg 4. PVR: biphasic 8. If subject has two or more ulcers, they must be separated by 2 cm. The largest ulcer satisfying the inclusion and
Exclusion criteria
will be designated as the target ulcer. 9. Target ulcer must be located on the plantar aspect of the foot and must be offloaded for at least 14 days prior to enrollment. 10. Subject must consent to using the prescribed offloading method for the duration of the study. 11. Subject must agree to attend weekly study visits. 12. Subject must be willing and able to participate in the consent process.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the percentage of subjects achieving complete closure of target ulcer over 12 weeks. | 1-12 weeks | The proportion of subjects achieving complete wound closure of target ulcer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to closure for target ulcer. | 1-12 weeks | Length of time in days to closure will be determined for each treatment group and compared to SOC alone. |
| Percent Area Reduction (PAR) | 1-12 weeks | Percent Area Reduction (PAR) will be calculated from Treatment Visit (TV)-1 to TV-13 measured weekly with digital photographic planimetry, using imaging device, and physical examination. |
| Adverse Events | 1-12 weeks | Determine number of adverse events |
| Change in pain in target ulcer | 1-12 weeks | Change in pain in target ulcer assessed using the Pain, Enjoyment of Life and General Activity (PEG) scale |
| Determine improvement in quality of life | 1-12 weeks | Quality of life assessed using the Wound Quality of Life (wQOL) at TV-1, TV-4, TV-8, TV-12 / Final Visit |
Countries
United States
Contacts
Primary ContactBennett Rogers
Backup ContactConnie Chung, PhD
Outcome results
None listed