Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Becaplermin/Promagran Dressing | Experimental | Topical Becaplermin with a protease inhibitor wound dressing. |
|
| Becaplermin/Placebo Dressing | Active Comparator | Topical Becaplermin with a placebo wound dressing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Chronic Wound Healing at 4 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steve Phillips, MSc | Contact | 905-521-2100 | 44167 | phills3@mcmaster.ca |
| Name | Affiliation | Role |
|---|---|---|
| Michael Stacey, MBBS, Doctor of Surgery | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29703712 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077214 | Becaplermin |
| ID | Term |
|---|---|
| D020574 | Proto-Oncogene Proteins c-sis |
| D010982 | Platelet-Derived Growth Factor |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Promagran Dressing | Device | 44% oxidized regenerated cellulose (ORC), 55% collagen and 1% silver-ORC wound dressing applied 3 times per week for 4 weeks. |
|
| Placebo Dressing | Device | Inactive wound dressing. |
|
|
Chronic wound healing will be measured using the VISITRAK device, which traces the outline of the chronic wound.
| 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. | 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. | 6 weeks |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003925 | Diabetic Angiopathies |
| D016523 | Foot Ulcer |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004268 | DNA-Binding Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |