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Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers

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ClinicalTrials.gov Identifier: NCT01143727
Recruitment Status : Completed
First Posted : June 14, 2010
Results First Posted : May 31, 2013
Last Update Posted : May 31, 2013
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetic Foot Ulcers Drug: Santyl Drug: Tegaderm Hydrogel Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of SANTYL vs. Hydrogel in Debridement of Inflamed Diabetic Foot Ulcers
Study Start Date : July 2010
Primary Completion Date : October 2011
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A
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.

Primary Outcome Measures :
  1. Wound Appearance [ Time Frame: 28 days ]
    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 :
  1. Percent Change in Wound Area [ Time Frame: 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01143727

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

Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01143727     History of Changes
Other Study ID Numbers: 017-101-09-025
First Posted: June 14, 2010    Key Record Dates
Results First Posted: May 31, 2013
Last Update Posted: May 31, 2013
Last Verified: April 2013

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