CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 57 enrolled
Drug / intervention
Santyl +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01143714
NCT01143714Phase 4Completed

A Vehicle-Controlled Study to Determine the Effect of Four Weeks of Debridement With Collagenase Santyl Ointment (Santyl) on the Healing of Diabetic Foot Ulcers

Healthpoint·interventional·Posted Jun 14, 2010·Updated May 6, 2013

In Brief

A Phase 4 clinical trial evaluating Santyl and White Petrolatum for Diabetic Foot Ulcers. Completed, enrolled 57 participants across 6 sites.

Detailed Summary

The purpose of this study is to assess the effect of four weeks of treatment with Santyl Ointment, compared to White Petrolatum, on the change from baseline in wound area of diabetic foot ulcers over four weeks, and on the proportion of subjects achieving complete wound closure within 12 weeks from initiation of treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 14, 2010
Enrollment StartJun 1, 2010
Primary CompletionApr 1, 2012
Study CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.1 years ago

Interventions

Santyldrug

Apply an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.

White Petrolatumother

Apply an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.