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Santyl Applications to Diabetic Foot Ulcers

NCT02111291 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2016-02-17

No results posted yet for this study

Summary

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.

Conditions

  • Diabetic Foot Ulcers
  • Diabetic Foot Wounds

Interventions

BIOLOGICAL

Collagenase SANTYL® Ointment

Daily application directly to the ulcer bed, approximately 2 mm thick.

BIOLOGICAL

Hydrogel (if needed) and foam dressing

Daily application of hydrogel directly to the ulcer bed (if necessary), covered with foam dressing

Sponsors & Collaborators

  • Healthpoint

    lead INDUSTRY

Principal Investigators

  • Hebert B Slade, MD · Smith and Nephew Biotherapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States
  • Canada

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 NCT02111291 on ClinicalTrials.gov