Study of Combined Topical Growth Factor and Protease Inhibitor in Chronic Wound Healing

Phase 3

• Conditions: Venous Ulcer; Foot Ulcer, Diabetic
• Interventions: Biological: Becaplermin; Device: Placebo Dressing; Device: Promagran Dressing

• Registration Number: NCT02845466
• Lead Sponsor: McMaster University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-07-14
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-27
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-06
• Last Update Posted: 2018-04-09
• Study Start: 2018-08
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Becaplermin/Promagran Dressing	Becaplermin	Topical Becaplermin with a protease inhibitor wound dressing.
Becaplermin/Placebo Dressing	Becaplermin	Topical Becaplermin with a placebo wound dressing.
Becaplermin/Placebo Dressing	Placebo Dressing	Topical Becaplermin with a placebo wound dressing.
Becaplermin/Promagran Dressing	Promagran Dressing	Topical Becaplermin with a protease inhibitor wound dressing.

Primary Outcome Measures

Name	Time	Method
Level of Applied Growth Factors in Chronic Wound Fluid	6 weeks	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

Name	Time	Method
Protease Levels in Chronic Wound Fluid	6 weeks	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	4 weeks	Chronic wound healing will be measured using the VISITRAK device, which traces the outline of the chronic wound.
WOUNDCHEK Device Validity	6 weeks	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	6 weeks	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.

Trial Locations

Locations (1)

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada