Wound Edge Changes Following Treatment With Santyl
Primary Purpose
Diabetic Foot Ulcers, Diabetic Foot Wounds
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Collagenase Santyl Ointment
Placebo Comparator
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcers focused on measuring Diabetic, Foot, Ulcers, Wounds
Eligibility 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.
Sites / Locations
- Associated Foot and Ankle Specialists
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Collagenase Santyl
Vehicle Base
Arm Description
Ointment applied once daily
Applied once daily
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01197898
Brief Title
Wound Edge Changes Following Treatment With Santyl
Official Title
Evaluation of the Edge of Non-Healing Cutaneous Ulcers Following Debridement With Collagenase Santyl Ointment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
April 2012 (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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers, Diabetic Foot Wounds
Keywords
Diabetic, Foot, Ulcers, Wounds
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Collagenase Santyl
Arm Type
Experimental
Arm Description
Ointment applied once daily
Arm Title
Vehicle Base
Arm Type
Placebo Comparator
Arm Description
Applied once daily
Intervention Type
Biological
Intervention Name(s)
Collagenase Santyl Ointment
Intervention Description
Topical daily application
Intervention Type
Other
Intervention Name(s)
Placebo Comparator
Intervention Description
Topical daily application
Primary Outcome Measure Information:
Title
Change From Baseline in Extent of Presence/Absence of Epithelial Tongue.
Description
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.
Time Frame
28 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert B Slade, MD
Organizational Affiliation
Healthpoint
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Art J Tallis, DPM
Organizational Affiliation
Associated Foot & Ankle Specialists
Official's Role
Principal Investigator
Facility Information:
Facility Name
Associated Foot and Ankle Specialists
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Wound Edge Changes Following Treatment With Santyl
We'll reach out to this number within 24 hrs