Wound Edge Changes Following Treatment With Santyl

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcers; Diabetic Foot Wounds
• Intervention / Treatment: Biological: Collagenase Santyl Ointment; Other: Placebo Comparator

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • Associated Foot and Ankle Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Collagenase Santyl; Ointment applied once daily	Biological: Collagenase Santyl Ointment; Topical daily application
Placebo Comparator: Vehicle Base; Applied once daily	Other: Placebo Comparator; Topical daily application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Healthpoint
• Investigators: Principal Investigator: Art J Tallis, DPM, Associated Foot & Ankle Specialists

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: August 26, 2010
• First Submitted That Met QC Criteria: September 8, 2010
• First Posted (Estimate): September 9, 2010

Study Record Updates

• Last Update Posted (Estimate): May 30, 2013
• Last Update Submitted That Met QC Criteria: April 23, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Diabetic; Ulcers; Wounds; Foot
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: 017-101-09-029