NCT03010319

PriMatrix for the Management of Diabetic Foot Ulcers

Prospective, Multi-center, Randomized, Controlled Trial Evaluating the Use of PriMatrix Dermal Repair Scaffold for the Management of Diabetic Foot Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the management of diabetic foot ulcers in subjects with diabetes mellitus versus the Standard of Care treatment. Half of patients will be treated using PriMatrix while the other half will receive Standard of Care treatment.

Detailed description

A diabetic foot ulcer (DFU) is a major health complication that affects up to 15% of individuals with diabetes mellitus over their lifetime. The treatment of DFUs is extremely challenging as these ulcers may not respond to standard of care (SC) treatment and frequently become infected. Advanced wound therapies like PriMatrix have become an important strategy in the treatment of hard-to-heal chronic DFUs by trapping and binding the patients' own cells to rebuild the dermis layer of the skin to aid in healing. The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the closure of DFUs in subjects with diabetes mellitus in comparison to Standard of Care treatment.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	PriMatrix Dermal Repair Scaffold	Application of PriMatrix to ulcer
DEVICE	Secondary Dressings	Dressings to ensure moist wound environment
DEVICE	Offloading device	Offloading device to decrease pressure to wound area

Timeline

• Start date: 2017-01-01
• Primary completion: 2020-08-01
• Completion: 2020-08-01
• First posted: 2017-01-05
• Last updated: 2022-04-29
• Results posted: 2022-03-15

Locations

17 sites across 1 country: United States