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

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ClinicalTrials.gov Identifier: NCT02845466
Recruitment Status : Not yet recruiting
First Posted : July 27, 2016
Last Update Posted : April 9, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Venous Ulcer Foot Ulcer, Diabetic Biological: Becaplermin Device: Promagran Dressing Device: Placebo Dressing Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Proof of Concept Study of Combined Topical Growth Factor and Protease Inhibitor in Chronic Wound Healing
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Becaplermin/Promagran Dressing
Topical Becaplermin with a protease inhibitor wound dressing.
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.
Other Name: Regranex

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

Active Comparator: Becaplermin/Placebo Dressing
Topical Becaplermin with a placebo wound dressing.
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.
Other Name: Regranex

Device: Placebo Dressing
Inactive wound dressing.
Other Name: Aquacel




Primary Outcome Measures :
  1. Level of Applied Growth Factors in Chronic Wound Fluid [ Time Frame: 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 :
  1. Protease Levels in Chronic Wound Fluid [ Time Frame: 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.

  2. Chronic Wound Healing at 4 Weeks [ Time Frame: 4 weeks ]
    Chronic wound healing will be measured using the VISITRAK device, which traces the outline of the chronic wound.

  3. WOUNDCHEK Device Validity [ Time Frame: 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.

  4. Levels of Healing Biomarkers in Chronic Wound Fluid [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02845466


Contacts
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Contact: Steve Phillips, MSc 905-521-2100 ext 44167 phills3@mcmaster.ca

Locations
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Canada, Ontario
Hamilton General Hospital Not yet recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Steve Phillips, MSc    905-521-2100 ext 44167    phills3@mcmaster.ca   
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Michael Stacey, MBBS, Doctor of Surgery McMaster University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02845466     History of Changes
Other Study ID Numbers: Lower Limb Ulcer Topical Ther
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by McMaster University:
Venous Leg Ulcer
Diabetic Foot Ulcer
Wound Healing
Growth Factor
Protease Inhibitor
Additional relevant MeSH terms:
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Varicose Ulcer
Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Diabetic Angiopathies
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
HIV Protease Inhibitors
Becaplermin
Mitogens
Protease Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anticoagulants
Angiogenesis Inducing Agents