NCT05506215

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

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.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: PolyNovo Biomaterials Pty Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Diabetic Foot
• Chronic Foot Ulcer
• Wound Healing
• Foot Ulcer

Interventions

Type	Name	Description
DEVICE	SynPath Acellular Dermal Matrix plus Off-loading Device	Application of SynPath
DEVICE	Wound Dressing composed of 90% collagen and 10% Alginate plus Off-loading Device	Application Wound Dressing composed of Collagen and Alginate

Timeline

• Start date: 2022-07-10
• Primary completion: 2024-02-26
• Completion: 2024-02-26
• First posted: 2022-08-18
• Last updated: 2024-03-05

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study