Back to resultsEnzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers
Primary Purpose
Diabetic Foot Ulcers
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Santyl
Tegaderm Hydrogel
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetic Foot Ulcers
Eligibility 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.
Sites / Locations
- Richard C. Galperin, DPM
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A
B
Arm Description
Santyl
Tegaderm Hydrogel
Outcomes
Primary Outcome Measures
Wound Appearance
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01143727
Brief Title
Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers
Official Title
Comparison of SANTYL vs. Hydrogel in Debridement of Inflamed Diabetic Foot Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Healthpoint
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Santyl
Arm Title
B
Arm Type
Active Comparator
Arm Description
Tegaderm Hydrogel
Intervention Type
Drug
Intervention Name(s)
Santyl
Intervention Description
Apply one 24-hr period sufficient to cover the wound.
Intervention Type
Drug
Intervention Name(s)
Tegaderm Hydrogel
Intervention Description
Apply once 24-hr period sufficient to cover the wound.
Primary Outcome Measure Information:
Title
Wound Appearance
Description
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.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Percent Change in Wound Area
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert B Slade, MD
Organizational Affiliation
Healthpoint
Official's Role
Study Chair
Facility Information:
Facility Name
Richard C. Galperin, DPM
City
Dallas
State/Province
Texas
ZIP/Postal Code
75224
Country
United States
12. IPD Sharing Statement
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Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers
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