Status:
COMPLETED
Clinical Study to Compare Two Skin Substitute Categories for Their Effectiveness to Treat Diabetic Foot Ulcers
Lead Sponsor:
Encoll Corp
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA cleared advanced skin substitute. The commercially available product is Helicoll® Advanc...
Eligibility Criteria
Inclusion
- 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 diabetic foot ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 10.0 cm2 measured post debridement using a ruler to measure wound area.
- 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 full thickness on the foot or ankle that does not probe to bone.
- Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:
- TCOM ≥30 mmHg
- ABI between 0.7 and 1.3
- PVR: Biphasic
- TBI ˃0.6
- As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle of the target extremity.
- 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 off-loading method for the duration of the study.
- The subject must agree to attend the twice-weekly/weekly study visits required by the protocol.
- The subject must be willing and able to participate in the informed consent process.
- Patients must have read and signed the IRB approved ICF before screening procedures are undertaken.
Exclusion
- A subject known to have a life expectancy of \< 6 months.
- If the target ulcer is infected or if there is cellulitis in the surrounding skin.
- Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
- A subject has an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
- A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy.
- Topical application of steroids to the ulcer surface within one month of initial screening.
- A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
- A subject with a glycated hemoglobin (HbA1c) greater than or equal to 13% taken at or within 3 months of the initial screening visit.
- A subject with a serum creatinine ≥ 3.0mg/dL within 6 months of the initial screening visit.
- A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer.
- Women who are pregnant or considering becoming pregnant within the next 6 months.
- A subject with end stage renal disease requiring dialysis.
- A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
- A subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments.
- A subject treated with hyperbaric oxygen therapy or a Cellular and/or Tissue Product (CTP) in the 30 days prior to the initial screening visit.
- A subject who has a sensitivity to bovine (cattle) or ovine (sheep) material.
- A subject that is allergic to aminoglycoside antibiotics (gentamycin, tobramycin, etc.)
Key Trial Info
Start Date :
July 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06557122
Start Date
July 25 2024
End Date
October 25 2024
Last Update
May 22 2025
Active Locations (3)
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1
Clemente Clinical Research
Los Angeles, California, United States, 90033
2
Doctors Research Network
South Miami, Florida, United States, 33143
3
Foot and Ankle Specialists of the Mid-Atlantic
Salem, Virginia, United States, 24153