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Randomized Clinical Study Comparing SynPath to Standard of Care in Treatment of Chronic Diabetic Foot Ulcers — DFUs  

Diabetic Foot Clinical Trial

Official title:
A Prospective, Multicenter, Open Label, Randomized, Controlled Clinical Study Evaluating the Effect of NovoSorb ® SynPath™ Dermal Matrix Compared to Standard of Care (SOC) In the Treatment of Nonresponsive, Chronic Diabetic Foot Ulcers.

Clinical Trial Summary

The study will evaluate the efficacy of SynPath™, a synthetic dermal matrix, in the treatment of diabetic foot ulcers in subjects with diabetes mellitus versus Standard of Care treatment. Half the subjects with be treated using SynPath™ while the other half will receive Standard of Care treatment

Clinical Trial Description

One hundred and thirty-eight (138) subjects with chronic Diabetic Foot Ulcers ranging in size from 1cm2 to 25cm2 will be randomized 1:1 to either SynPath™ or Standard of Care after the completion of a 14 day screening/run-in period. Following the of run-in period the subjects with a 'hard to heal' or chronic, (>4 weeks) nonresponsive Wagner Grade 1 or 2 diabetic foot ulcer will be randomized to receive either SynPath™ or SOC treatment. Both treatment groups will require subjects to use off-loading device. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05506215
Study type Interventional
Source PolyNovo Biomaterials Pty Ltd.
Contact
Status Terminated
Phase N/A
Start date July 10, 2022
Completion date February 26, 2024
View Details
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