Lower Extremity Chronic Ulcers in Diabetics, Diabetic Foot Ulcer (DFU)
Conditions
Keywords
Diabetic Foot Ulcers, Chronic foot ulcers, Plantar Ulcers, Lower Extremity Ulcers, Amniotic Tissues, HCT/P, 361 products, Q4190
Brief summary
This is study is to determine if A tri-layered dehydrated human amnion/chorion/amnion composite graft would help non-healing lower extremity diabetic ulcers to heal over a 12 week time period.
Detailed description
This is study is to determine if A tri-layered dehydrated human amnion/chorion/amnion composite graft would help non-healing lower extremity diabetic ulcers to heal over a 12 week time period. During this trial the patient will undergo a screening period where SOC is used to see if the patient will respond and heal \> 20% of the surface area in 2 weeks. if the patient can not heal more than 20% in two week the patient then will receive a trial-layered human amnion/chorion/amnion composite graft weekly for 12 week and precent wound area reduction and complete wound healing will be recorded.
Interventions
OTHERamniotic membrane
The intervention is a trial-layer human amnion/chorion/amnion composite graft
Sponsors
Serena Group
Tides Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects will be eligible to participate in the study if all the following conditions exist: Potential subjects are required to meet all the following criteria for enrollment into the study. 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 entry 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 with the MolecuLight Imaging HCT/P 361 . 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 full thickness without exposed 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 between 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. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment. 10. The subject must consent to using the prescribed off-loading method for the duration of the study. 11. The subject must agree to attend the weekly study visits required by the protocol. 12. The subject must be willing and able to participate in the informed consent process.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of wound closure by percent of complete epithelialization | 12 weeks | complete wound closure measured by 100% epithelialization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent area reduction | 12 weeks | Precent of the wound which has been re-epithelialized |
Countries
United States
Outcome results
None listed