NCT02845466

Study of Combined Topical Growth Factor and Protease Inhibitor in Chronic Wound Healing

Proof of Concept Study of Combined Topical Growth Factor and Protease Inhibitor in Chronic Wound Healing

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Leg and foot ulcers due to venous disease or diabetes are chronic wounds that can take 6 or more months to heal. Growth factors have been used to try and improve this healing, however, many such studies have failed, and that is thought to be due enzymes in the wound that degrade the growth factors and prevent them from working. This is a proof of concept study that will evaluate the treatment of chronic leg ulcers with topically applied growth factors that are combined with a therapy to prevent their inactivation in the wound.

Conditions

• Venous Ulcer
• Foot Ulcer, Diabetic

Interventions

Type	Name	Description
BIOLOGICAL	Becaplermin	0.25 cm of 100 µg/g Becaplermin gel topically per 1cm² of ulcer area applied 3 times per week for 6 weeks.
DEVICE	Promagran Dressing	44% oxidized regenerated cellulose (ORC), 55% collagen and 1% silver-ORC wound dressing applied 3 times per week for 4 weeks.
DEVICE	Placebo Dressing	Inactive wound dressing.

Timeline

• Start date: 2018-08-01
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2016-07-27
• Last updated: 2018-04-09

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study
• FDA-regulated device study