Wound Edge Changes Following Treatment With Santyl

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT01197898
First received: August 26, 2010
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Diabetic Foot Ulcers
Diabetic Foot Wounds
Biological: Collagenase Santyl Ointment
Other: Placebo Comparator
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Edge of Non-Healing Cutaneous Ulcers Following Debridement With Collagenase Santyl Ointment

Resource links provided by NLM:


Further study details as provided by Healthpoint:

Primary Outcome Measures:
  • Change From Baseline in Extent of Presence/Absence of Epithelial Tongue. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    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.


Enrollment: 10
Study Start Date: December 2010
Study Completion Date: October 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
    • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197898

Locations
United States, Arizona
Associated Foot and Ankle Specialists
Phoenix, Arizona, United States, 85015
Sponsors and Collaborators
Healthpoint
Investigators
Study Chair: Herbert B Slade, MD Healthpoint
Principal Investigator: Art J Tallis, DPM Associated Foot & Ankle Specialists
  More Information

No publications provided

Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01197898     History of Changes
Other Study ID Numbers: 017-101-09-029
Study First Received: August 26, 2010
Results First Received: March 13, 2013
Last Updated: April 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Healthpoint:
Diabetic
Foot
Ulcers
Wounds

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on July 22, 2014