NCT02312596

A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Non-Healing Diabetic Foot Ulcers

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: PRP Concepts, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, randomized, controlled, clinical study to establish clinical based evidence of PRP Concepts Fibrin Bio-Matrix and compare its performance with the usual and customary practice for the treatment of Wagner 1 or 2 DFUs.

Detailed description

This is a prospective, randomized, single-blind, controlled, multi-center study for subjects undergoing DFU treatment. Qualified subjects will be randomized (1:1); test group (PRP Concepts Fibrin Bio-Matrix) and control group (usual and customary practice). The study will consist of 3 periods: a screening period, an active treatment period, and a follow-up period (if healed). Approximately 250 subjects will be enrolled. Subjects will be ≥18 years of age with a chronic Wagner grade 1 or 2 DFU (greater than 1 month duration). Each subject will be enrolled in the active treatment period for up to 12 weeks, or to closure of wound with a confirmatory visit 2 weeks after wound closure, whether such closure occurs at 12 weeks or earlier.

Conditions

• Diabetic Foot Ulcers

Interventions

Type	Name	Description
DEVICE	PRP Concepts Fibrin Bio-Matrix	Application of PRP Concepts Fibrin Bio-Matrix in addition to usual and customary practice
OTHER	Usual and Customary Practice	Usual and customary care for non-healing wounds

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2014-12-09
• Last updated: 2021-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study