Evaluation of the Edge of Non-Healing Cutaneous Ulcers Following Debridement With Collagenase Santyl Ointment

Healthpoint1 site in 1 country10 target enrollmentDecember 2010

ConditionsDiabetic Foot Ulcers Diabetic Foot Wounds

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Diabetic Foot Ulcers
Sponsor: Healthpoint
Enrollment: 10
Locations: 1
Primary Endpoint: Change From Baseline in Extent of Presence/Absence of Epithelial Tongue.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this study is to evaluate changes in the healing tissue of diabetic foot wounds following 14 days of treatment with Santyl or its vehicle base.

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

October 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Healthpoint

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•To be eligible for the study, subjects must meet the following inclusion criteria:
•Subjects should be presenting for the first time with a complaint of a non-healing wound, or may have failed one or more prior inadequate therapies. To improve homogeneity in the group studied, subjects with large wounds, complicated wounds, wounds of long duration, or who have failed multiple attempts at healing in which additional known critical variables were addressed (debridement, off loading, wound moisture control, wound infection control, blood glucose control, and/or adequate local blood supply) will be excluded.
•Provide written informed consent.
•Subjects 18 years of age or older, of either sex and of any race, with an existing diagnosis of Type I or Type II Diabetes Mellitus.
•Presenting for the first time with a complaint of a non-healing wound, or may have failed one or more prior inadequate therapies but not including therapies generally reserved for chronic wounds (i.e., debridement, off loading, wound moisture control, wound infection control, blood glucose control, and/or adequate local blood supply).
•Willing to attend all required study visits, and in the opinion of the Investigator, able to properly follow instructions regarding daily dressing changes (dressing changes may be done by a third party, who must agree to perform these daily).
•Body Mass Index less than or equal to 40
•A foot wound which meets the following criteria:
•Time since initial skin breakdown 56 - 112 days
•Wagner† Grade 1

Exclusion Criteria

•Subjects meeting any of the following criteria during the screening period will be excluded from the study:
•Contraindications or hypersensitivity to the use of the study medications or their components
•Therapy with another investigational agent within thirty (30) days of Visit
•Calluses or maceration of periwound area which would interfere with successful biopsy of the wound edge.
•Undermining or tunneling of the target wound.
•Evidence of osteomyelitis on screening roentgenogram of the target foot.
•Coagulation defect or bleeding disorder which, in the opinion of the Investigator, will make the biopsy procedures too risky.
•The Medical Monitor may declare any subject ineligible for a valid medical reason.

Outcomes

Primary Outcomes

Change From Baseline in Extent of Presence/Absence of Epithelial Tongue.

Time Frame: 28 Days

The results were found to be inconclusive due to the small number of biopsy specimens of sufficient quality for analysis. Four of the 10 subjects enrolled were not evaluable due to poor biopsy quality.