Wound Edge Changes Following Treatment With Santyl

Diabetic Foot Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197898
• Other study ID #: 017-101-09-029
• Status: Completed
• Phase: Phase 4
• First received: August 26, 2010
• Last updated: April 23, 2013
• Start date: December 2010
• Est. completion date: October 2012

Study information

• Verified date: April 2013
• Source: Healthpoint
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• Area between 0.75 and 3.0 cm2, inclusive

• Located on plantar surface of midfoot or forefoot, dorsum of foot, or a post-amputation wound

• Non-infected based on clinical assessment

• Adequate blood supply to the affected foot, defined as meeting a transcutaneous oxygen pressure(TcPO2) measured using standard technique and within 4 cm of the wound of greater than or equal to 35 mmHg.

• Blood chemistry and hematology values as follows, using local lab normal ranges unless otherwise specified:

• Blood Glycated Hemoglobin (HbA1C) 6.5 - 10.5%

• Blood Glucose less than or equal to 180 mg/dL

• Blood Hemoglobin, Hematocrit, Red Blood Cell count within normal limits

• Serum Sodium, Potassium, Calcium, Phosphorus, Carbon Dioxide (CO2) within normal limits

• Serum Albumin greater than or equal to 2.0 g/dL, serum Pre-Albumin greater than or equal to 15 mg/dL

• Alanine Transaminase (ALT), Aspartate Transaminase (AST), Gamma Glutamyl Transpeptidase (GGT) less than or equal to 2.0 x Upper Limit of Normal (ULN)

• Blood Urea Nitrogen, Total Bilirubin, Creatinine less than or equal to 1.5 x ULN

• Wound is able to be off-loaded, if indicated. † Wagner Grade 1 = Superficial ulcer, partial or full-thickness, but not involving underlying fat, fascia, tendon, muscle or bone.

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 1.

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Diabetic Foot Wounds

Intervention

Biological:
• Collagenase Santyl Ointment
Topical daily application

Other:
• Placebo Comparator
Topical daily application

Locations

Country	Name	City	State
United States	Associated Foot and Ankle Specialists	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Healthpoint

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Extent of Presence/Absence of Epithelial Tongue.	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.	28 Days	No