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

Foot Ulcer, Diabetic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02845466
• Other study ID #: Lower Limb Ulcer Topical Ther
• Status: Not yet recruiting
• Phase: Phase 3
• First received: July 14, 2016
• Last updated: April 6, 2018
• Start date: August 2018
• Est. completion date: September 2020

Study information

• Verified date: April 2018
• Source: McMaster University
• Contact: Steve Phillips, MSc
• Phone: 905-521-2100
• Email: phills3[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic
• Ulcer
• Varicose Ulcer
• Venous Ulcer

Intervention

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

Device:
• Promagran Dressing
44% oxidized regenerated cellulose (ORC), 55% collagen and 1% silver-ORC wound dressing applied 3 times per week for 4 weeks.
• Placebo Dressing
Inactive wound dressing.

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Secondary	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.	6 weeks
Secondary	Chronic Wound Healing at 4 Weeks	Chronic wound healing will be measured using the VISITRAK device, which traces the outline of the chronic wound.	4 weeks
Secondary	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.	6 weeks
Secondary	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.	6 weeks