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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® Advanced Skin Substitute.
In this trial two groups of subjects with Wagner 1 diabetic foot ulcers (DFUs), will receive standard of care (SOC) treatment for their condition. Half of the patients will have their SOC treatment with Epifix® or Grafix® and the other half will receive a 510K FDA cleared Helicoll® Advanced Skin Substitute as the primary treatment. The primary endpoint is the percentage wound area reduction of the target ulcer. Secondary endpoints include the proportion of subjects that obtain complete closure over the 5-week treatment period, the time to achieve complete wound closure of the target ulcer by the end of 5 weeks, and mean number of IP applications.
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Inclusion criteria
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:
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 criteria
Primary purpose
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Interventional model
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24 participants in 2 patient groups
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Central trial contact
Charles M Zelen, DPM, FACFAS
Data sourced from clinicaltrials.gov
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