Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT01143727
First received: June 11, 2010
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

This study compares two standard methods for cleaning the surface of wounds on the feet of patients with diabetes mellitus. The question being asked is whether inflammation of the wound affects the ability of one or both of the methods to work.


Condition Intervention Phase
Diabetic Foot Ulcers
Drug: Santyl
Drug: Tegaderm Hydrogel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison of SANTYL vs. Hydrogel in Debridement of Inflamed Diabetic Foot Ulcers

Resource links provided by NLM:


Further study details as provided by Healthpoint:

Primary Outcome Measures:
  • Wound Appearance [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Weekly wound appearance as assessed by BWAT-m scores. BWAT-m scores used to determine primary efficacy consist of 8 subscales, each grade an aspect of wound status on a 1-5 scale; 1=normal intact skin; 5=least desirable. Total score=8-40. Subscales: Edges, Undermining, Necrotic Tissue Type, Necrotic Tissue Amount, Exudate Type, Exudate Amount, Skin Color Surrounding Wound, and Granulation Tissue.


Secondary Outcome Measures:
  • Percent Change in Wound Area [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: July 2010
Study Completion Date: October 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Santyl
Drug: Santyl
Apply one 24-hr period sufficient to cover the wound.
Active Comparator: B
Tegaderm Hydrogel
Drug: Tegaderm Hydrogel
Apply once 24-hr period sufficient to cover the wound.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams. In addition, the informed consent document must be signed and dated by the individual who consents the subject before conducting the screening visit. A photocopy of the signed informed consent document must be provided to the subject, and the original signed document placed in the subject's chart.
  • Of either sex, aged 18 years or older.
  • A diagnosis of Diabetes Mellitus, Type I or II, requiring medication to control blood glucose levels.
  • A qualifying ulcer, defined as follows:

    • Ulcer grade 1 or 2 on the Wagner Classification Scale (refer to Section 9.4.1)
    • Infection / inflammation grade 1 or 2 for wound bed inflammation (refer to Section 9.4.2)
    • Has not been treated or has not responded to treatment during the past 30 days
    • Has an apparent area ≥ 3.0 cm²
  • Requires debridement of the wound bed
  • Is sufficiently moist to allow collection of wound fluid using a filter paper disc
  • Adequate arterial blood flow evidenced by ankle brachial index (ABI) of ≥ 0.7 and ≤ 1.1; if the ABI is greater than 1.1, then toe pressure of >50 mmHg.
  • Subject must be willing to use the Darco shoe off-loading device and insole, or a comparable device, as indicated.
  • Subject able to follow instructions, particularly regarding the application of test articles and dressings at home. Able to apply the test articles, or has a caregiver available to apply the test articles according to the protocol.

Exclusion Criteria:

  • Contraindications or known hypersensitivity to the test articles or their components.
  • Cellulitis extending >2 cm around the target ulcer, lymphangitic streaking, spread beneath the superficial fascia, deep-tissue abscess, gangrene, or infection of muscle, tendon, joint or bone.
  • Target ulcer tunneling per probing and visual assessment.
  • Use of systemic antibiotics or any drug listed in Section 9.1.6 of this protocol within 10 days of SCR visit.
  • Concomitant illness or condition which, in the opinion of the Principal - Investigator, places the subject at risk for this study.
  • The Medical Monitor may declare any subject ineligible for a valid procedural or medical reason.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01143727

Locations
United States, Texas
Richard C. Galperin, DPM
Dallas, Texas, United States, 75224
Sponsors and Collaborators
Healthpoint
Investigators
Study Chair: Herbert B Slade, MD Healthpoint
  More Information

No publications provided

Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01143727     History of Changes
Other Study ID Numbers: 017-101-09-025
Study First Received: June 11, 2010
Results First Received: March 14, 2013
Last Updated: April 11, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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 April 15, 2014