Using Santyl on Diabetic Foot Ulcers

Phase 4

Completed

• Conditions: Diabetic Foot Ulcers; Diabetic Foot Wounds
• Interventions: Biological: Santyl; Procedure: Control

• Registration Number: NCT01408277
• Lead Sponsor: Healthpoint

Brief Summary

Subjects enrolled in this study will either use Santyl daily or follow standard care procedures for up to 6 weeks for their diabetic foot wound. After 6 weeks of treatment, the subjects will continue into the follow-up phase for an additional 6 weeks. Study doctors will look at the wound in the office each week (up to 12 weeks) to see if the wound is healing. Depending on a number of factors at each office visit, the study doctors may also use a procedure called sharp debridement to remove dead skin from the wound.

This study will test the hypothesis that daily treatment of diabetic foot wounds with Santyl will result in more rapid healing, healthier wounds, and fewer required sharp debridements over the study period than for diabetic foot wounds treated in other ways.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-02
• Study First Submitted QC: 2011-08-02
• Study First Posted: 2011-08-03
• Primary Completion: 2012-11
• Study Completion: 2013-03
• Results First Submitted: 2014-04-02
• Results First Submitted QC: 2014-04-02
• Results First Posted: 2014-05-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-30
• Last Update Posted: 2014-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Santyl	Santyl	2mm Santyl applied once daily.
Control	Control	Standard Care

Primary Outcome Measures

Name	Time	Method
Mean Percent Change in Wound Area	6 and 12 weeks	Wound area was measured using the ARANZ Silhouette digital wound imaging and measurement device. The average percent (%) of change from baseline of the target wound area at the end of the 6-week treatment period and the end of the entire 12-week study period respectively, was calculated using a two-way ANCOVA model.

Trial Locations

Locations (7)

Foot Healthcare Associates, PC; 🇺🇸 Southfield, Michigan, United States

Robert Wunderlich; 🇺🇸 San Antonio, Texas, United States

Endeavor Clinical Trials; 🇺🇸 San Antonio, Texas, United States

Aung Foothealth Clinics; 🇺🇸 Tucson, Arizona, United States

UNTHSC Fort Worth; 🇺🇸 Fort Worth, Texas, United States

Associated Foot and Ankle Specialists; 🇺🇸 Phoenix, Arizona, United States

Overlook Hospital Wound Care Center; 🇺🇸 Summit, New Jersey, United States