UnknownNot Applicable

Evaluate the Safety and Efficacy of RegenKit Autologous PRP Gel for the Treatment of Diabetic Foot Ulcer

United States192 participantsStarted 2018-04-12

Plain-language summary

Autologous platelet-rich plasma (PRP) gel was reported to have very good outcomes in the treatment of foot ulcers in pilot studies and retrospective uncontrolled trials. Therefore, a larger randomized, placebo-controlled clinical trial will be useful to determine whether platelet-rich plasma is safe and effective for the treatment of diabetic foot ulcers (DFU).

Who can participate

Age range18 Years – 95 Years

SexALL

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Inclusion criteria

✓. Ankle Brachial Index (ABI) between 0.60 and 1.30, or
✓. Patients with falsely elevated ABI values (equal to or greater than 1.30) due to non-compressible ankle vessels:

What they're measuring

Proportion of patients with complete wound closure

Timeframe: 16 weeks

Trial details

NCT IDNCT02402374

SponsorRegen Lab SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-10-30

View on ClinicalTrials.gov More Diabetic Foot Ulcers trials