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A Study to Look at the Effects of Four Weeks of Treatment on the Healing of Diabetic Foot Ulcers

NCT01143714 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2013-05-06

Study results available
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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.

Conditions

  • Diabetic Foot Ulcers

Interventions

DRUG

Santyl

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.

OTHER

White Petrolatum

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.

Sponsors & Collaborators

  • Healthpoint

    lead INDUSTRY

Principal Investigators

  • Herbert B Slade, MD · Healthpoint

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-04-30
Completion
2012-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01143714 on ClinicalTrials.gov