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

NCT02845466 | Unknown Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: Lower Limb Ulcer Topical Ther
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Ulcer; Foot Ulcer, Diabetic

Keywords

Venous Leg Ulcer; Diabetic Foot Ulcer; Wound Healing; Growth Factor; Protease Inhibitor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Protease Levels in Chronic Wound Fluid

  6 weeks

• Chronic Wound Healing at 4 Weeks

  4 weeks

• WOUNDCHEK Device Validity

  6 weeks

• Levels of Healing Biomarkers in Chronic Wound Fluid

  6 weeks

Study Arms (2)

Becaplermin/Promagran Dressing

EXPERIMENTAL

Topical Becaplermin with a protease inhibitor wound dressing.

Biological: Becaplermin; Device: Promagran Dressing

Becaplermin/Placebo Dressing

ACTIVE COMPARATOR

Topical Becaplermin with a placebo wound dressing.

Biological: Becaplermin; Device: Placebo Dressing

Interventions

Becaplermin BIOLOGICAL

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

Also known as: Regranex

Becaplermin/Placebo Dressing; Becaplermin/Promagran Dressing

Promagran Dressing DEVICE

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

Becaplermin/Promagran Dressing

Placebo Dressing DEVICE

Inactive wound dressing.

Also known as: Aquacel

Becaplermin/Placebo Dressing

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (1)

• 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.

  PMID: 29703712 DERIVED

MeSH Terms

Conditions

Varicose Ulcer; Diabetic Foot

Interventions

Becaplermin

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Foot Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Proto-Oncogene Proteins c-sis; Platelet-Derived Growth Factor; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; DNA-Binding Proteins; Proteins; Biological Factors

Study Officials

• Michael Stacey, MBBS, Doctor of Surgery

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steve Phillips, MSc

CONTACT

905-521-2100; phills3@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 27, 2016
• Study Start: August 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 9, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)