Who is sponsoring NCT02111291?

NCT02111291 is sponsored by Healthpoint.

What condition does NCT02111291 study?

NCT02111291 studies Diabetic Foot Ulcers, Diabetic Foot Wounds.

What drugs are being tested in NCT02111291?

Interventions: Collagenase SANTYL® Ointment, Hydrogel (if needed) and foam dressing.

What is the status of NCT02111291?

NCT02111291 is currently COMPLETED.

Last reviewed 2016-02-16 · How we verify

Clinical Outcomes Associated With Enzymatic Debridement of Diabetic Foot Ulcers for Up To 12 Weeks With Clostridial Collagenase (Santyl®) Ointment

NCT02111291 Phase 4 COMPLETED

The current trial examines the potential benefits of continuous 12 week treatment with Santyl, measured in terms of wound bed appearance. The visual appearance of granulation tissue will be recorded at each visit for the purpose of examining the relationship between wound bed appearance and progress towards healing. In support of this longer treatment regimen with Santyl, a recent animal study found that application of Santyl for 12 weeks was safe and well tolerated. Therefore, the present study is designed to test the hypothesis that daily treatment of diabetic foot ulcers (DFU) with Santyl for up to 12 weeks will result in more rapid development of granulation tissue than DFU treated with supportive care.

Details

Lead sponsor	Healthpoint
Phase	Phase 4
Status	COMPLETED
Enrolment	215
Start date	2014-04
Completion	2015-12

Conditions

Diabetic Foot Ulcers
Diabetic Foot Wounds

Interventions

Collagenase SANTYL® Ointment
Hydrogel (if needed) and foam dressing

Primary outcomes

Time to Well-established Granulation Tissue — 12 Weeks

Countries

United States, Canada