Foot Ulcer, Diabetic, Venous Ulcer
Conditions
Keywords
Venous Leg Ulcer, Diabetic Foot Ulcer, Wound Healing, Growth Factor, Protease Inhibitor
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.
Interventions
BIOLOGICALBecaplermin
0.25 cm of 100 µg/g Becaplermin gel topically per 1cm² of ulcer area applied 3 times per week for 6 weeks.
DEVICEPromagran Dressing
44% oxidized regenerated cellulose (ORC), 55% collagen and 1% silver-ORC wound dressing applied 3 times per week for 4 weeks.
DEVICEPlacebo Dressing
Inactive wound dressing.
Sponsors
Canadian Institutes of Health Research (CIHR)
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Contacts
Primary ContactSteve Phillips, MSc
Outcome results
None listed