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

McMaster University80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Venous Ulcer Foot Ulcer, Diabetic

Interventions

BecaplerminBIOLOGICAL

0.25 cm of 100 µg/g Becaplermin gel topically per 1cm² of ulcer area applied 3 times per week for 6 weeks.

Promagran DressingDEVICE

44% oxidized regenerated cellulose (ORC), 55% collagen and 1% silver-ORC wound dressing applied 3 times per week for 4 weeks.

Placebo DressingDEVICE

Inactive wound dressing.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Hamilton General Hospital

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: 6 weeks

Secondary Outcomes

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.

Time frame: 6 weeks

Chronic Wound Healing at 4 Weeks

Chronic wound healing will be measured using the VISITRAK device, which traces the outline of the chronic wound.

Time frame: 4 weeks

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.

Time frame: 6 weeks

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.

Time frame: 6 weeks

Central Contacts

Steve Phillips, MSc

CONTACT

905-521-2100 phills3@mcmaster.ca

Data from ClinicalTrials.gov

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