search
Back to results

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
Healthpoint
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcers focused on measuring Diabetic, Foot, Ulcers, Wounds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 26, 2010
Last Updated
April 23, 2013
Sponsor
Healthpoint
search

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