Study of Combined Topical Growth Factor and Protease Inhibitor in Chronic Wound Healing
Primary Purpose
Venous Ulcer, Foot Ulcer, Diabetic
Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Becaplermin
Promagran Dressing
Placebo Dressing
Sponsored by
About this trial
This is an interventional treatment trial for Venous Ulcer focused on measuring Venous Leg Ulcer, Diabetic Foot Ulcer, Wound Healing, Growth Factor, Protease Inhibitor
Eligibility Criteria
Inclusion Criteria:
- Men and women aged ≥18 years
- Ulcer size 1-64 cm²
- Ulcer extends through both the epidermis and dermis, with no exposed tendon or bone
- Ulcer duration >3 months
- Ulcer located between and including the knee and ankle
- For venous leg ulcers - Venous refilling time <25s on photoplethysmography or abnormal venous insufficiency Duplex scan
- For diabetic foot ulcers - confirmed type 1 or type 2 diabetes mellitus with a haemoglobin A1C < 12%
- Wounds have not been treated with Promogran in the previous 4 weeks
- Patients able to give informed consent
Exclusion Criteria:
- Ankle-brachial index <0.8
- Ulcer with local or systemic signs of infection
- Patients who have been previously treated with Becaplermin gel
- Receiving corticosteroids or immune suppressants
- History of autoimmune disease
- Uncontrolled diabetes (baseline haemoglobin A1C > 12%)
- Severe rheumatoid arthritis
- Uncontrolled congestive heart failure
- Malnutrition (albumin <2.5g/dL)
- Unable to adhere to the protocol
- Known sensitivities to the wound dressings used in the trial
- A history of any previous malignancy
- pregnant or lactating women
Sites / Locations
- Hamilton General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Becaplermin/Promagran Dressing
Becaplermin/Placebo Dressing
Arm Description
Topical Becaplermin with a protease inhibitor wound dressing.
Topical Becaplermin with a placebo wound dressing.
Outcomes
Primary Outcome Measures
Level of Applied Growth Factors in Chronic Wound Fluid
The levels of the growth factors applied to the chronic wound will be measured using samples of the wound fluid gathered at the first two visits each week.
Secondary Outcome Measures
Protease Levels in Chronic Wound Fluid
The levels of enzyme activity in the chronic wound will be measured using samples of the wound fluid gathered at the first two visits each week.
Chronic Wound Healing at 4 Weeks
Chronic wound healing will be measured using the VISITRAK device, which traces the outline of the chronic wound.
WOUNDCHEK Device Validity
The WOUNDCHEK device will be used in order to test for levels of enzyme activity in the chronic wound. This data will then be compared to the enzyme activity as determined by the levels analyzed in the chronic wound fluid.
Levels of Healing Biomarkers in Chronic Wound Fluid
The levels of the potential biomarker of healing GMCSF in the chronic wound fluid will be measured using samples of the chronic wound fluid collected at the first two visits each week.
Full Information
NCT ID
NCT02845466
First Posted
July 14, 2016
Last Updated
April 6, 2018
Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT02845466
Brief Title
Study of Combined Topical Growth Factor and Protease Inhibitor in Chronic Wound Healing
Official Title
Proof of Concept Study of Combined Topical Growth Factor and Protease Inhibitor in Chronic Wound Healing
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2018 (Anticipated)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Leg and foot ulcers due to venous disease or diabetes are chronic wounds that can take 6 or more months to heal. Growth factors have been used to try and improve this healing, however, many such studies have failed, and that is thought to be due enzymes in the wound that degrade the growth factors and prevent them from working. This is a proof of concept study that will evaluate the treatment of chronic leg ulcers with topically applied growth factors that are combined with a therapy to prevent their inactivation in the wound.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Ulcer, Foot Ulcer, Diabetic
Keywords
Venous Leg Ulcer, Diabetic Foot Ulcer, Wound Healing, Growth Factor, Protease Inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Becaplermin/Promagran Dressing
Arm Type
Experimental
Arm Description
Topical Becaplermin with a protease inhibitor wound dressing.
Arm Title
Becaplermin/Placebo Dressing
Arm Type
Active Comparator
Arm Description
Topical Becaplermin with a placebo wound dressing.
Intervention Type
Biological
Intervention Name(s)
Becaplermin
Other Intervention Name(s)
Regranex
Intervention Description
0.25 cm of 100 µg/g Becaplermin gel topically per 1cm² of ulcer area applied 3 times per week for 6 weeks.
Intervention Type
Device
Intervention Name(s)
Promagran Dressing
Intervention Description
44% oxidized regenerated cellulose (ORC), 55% collagen and 1% silver-ORC wound dressing applied 3 times per week for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Placebo Dressing
Other Intervention Name(s)
Aquacel
Intervention Description
Inactive wound dressing.
Primary Outcome Measure Information:
Title
Level of Applied Growth Factors in Chronic Wound Fluid
Description
The levels of the growth factors applied to the chronic wound will be measured using samples of the wound fluid gathered at the first two visits each week.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Protease Levels in Chronic Wound Fluid
Description
The levels of enzyme activity in the chronic wound will be measured using samples of the wound fluid gathered at the first two visits each week.
Time Frame
6 weeks
Title
Chronic Wound Healing at 4 Weeks
Description
Chronic wound healing will be measured using the VISITRAK device, which traces the outline of the chronic wound.
Time Frame
4 weeks
Title
WOUNDCHEK Device Validity
Description
The WOUNDCHEK device will be used in order to test for levels of enzyme activity in the chronic wound. This data will then be compared to the enzyme activity as determined by the levels analyzed in the chronic wound fluid.
Time Frame
6 weeks
Title
Levels of Healing Biomarkers in Chronic Wound Fluid
Description
The levels of the potential biomarker of healing GMCSF in the chronic wound fluid will be measured using samples of the chronic wound fluid collected at the first two visits each week.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women aged ≥18 years
Ulcer size 1-64 cm²
Ulcer extends through both the epidermis and dermis, with no exposed tendon or bone
Ulcer duration >3 months
Ulcer located between and including the knee and ankle
For venous leg ulcers - Venous refilling time <25s on photoplethysmography or abnormal venous insufficiency Duplex scan
For diabetic foot ulcers - confirmed type 1 or type 2 diabetes mellitus with a haemoglobin A1C < 12%
Wounds have not been treated with Promogran in the previous 4 weeks
Patients able to give informed consent
Exclusion Criteria:
Ankle-brachial index <0.8
Ulcer with local or systemic signs of infection
Patients who have been previously treated with Becaplermin gel
Receiving corticosteroids or immune suppressants
History of autoimmune disease
Uncontrolled diabetes (baseline haemoglobin A1C > 12%)
Severe rheumatoid arthritis
Uncontrolled congestive heart failure
Malnutrition (albumin <2.5g/dL)
Unable to adhere to the protocol
Known sensitivities to the wound dressings used in the trial
A history of any previous malignancy
pregnant or lactating women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steve Phillips, MSc
Phone
905-521-2100
Ext
44167
Email
phills3@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Stacey, MBBS, Doctor of Surgery
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steve Phillips, MSc
Phone
905-521-2100
Ext
44167
Email
phills3@mcmaster.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29703712
Citation
Stacey M. Combined Topical Growth Factor and Protease Inhibitor in Chronic Wound Healing: Protocol for a Randomized Controlled Proof-of-Concept Study. JMIR Res Protoc. 2018 Apr 27;7(4):e97. doi: 10.2196/resprot.8327.
Results Reference
derived
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Study of Combined Topical Growth Factor and Protease Inhibitor in Chronic Wound Healing
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