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The purpose of this trial is to determine if wounds with elevated protease activity (EPA) treated with targeted interventions such as protease modulating therapies can improve clinical and economic outcomes.
It is hypothesized that protease modulating dressings may provide significantly better clinical outcomes on EPA wounds over current standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Promogran and High EPA | Experimental | Wound with high EPA will be treated with promogran and covered with a secondary dressing that is standard of care |
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| Promogran and Low EPA | Experimental | Wounds with low EPA will be treated with Promogran and covered with a secondary which is standard of care |
|
| High EPA and standrad of care | Active Comparator | Wounds with high EPA will get standard of care as in line with current practice as they is no other test currently available for EPA |
|
| Low EPA and standard of care | Active Comparator | Low EPA wounds will be treated with the standard of care for diabetic foot ulcers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROMOGRAN | Device | PROMOGRAN® is a protease modulating dressing, formulated as a bioresorbable amorphous open-pored matrix constructed of 45% oxidised regenerated cellulose (ORC) and 55% bovine collagen |
| Measure | Description | Time Frame |
|---|---|---|
| To identify EPA wounds using WOUNDCHEK™ Protease Status diagnostic test, and to compare the healing outcomes of two treatment regimes (PROMOGRAN®, a protease modulating therapy and current standard of care) on chronic wounds with EPA. | An improved healing outcome for diabetic foot ulcers ulcers will be defined as the proportion of wounds which reach a minimum 50% percentage reduction in wound surface area over a four-week treatment period. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in wound area and cost effectiveness | The relative reductions in wound surface area from baseline over twelve weeks of treatment. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Breda Cullen, PHD | Contact | 01756747510 | breda.cullen@systagenix.com |
| Name | Affiliation | Role |
|---|---|---|
| Keith Harding, Prof | Cardiff University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn North Centers for advance wound care | Recruiting | Eire | Pennsylvania | 16544 | United States |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| Tielle | Device | Tielle is a hydropolymer foam dressing that is designed to provide optimal wound healing |
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| Diabetes Klinik Bad Mergentheim Gmbh&CO. KG | Recruiting | Bad Mergentheim | 97980 | Germany |
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| University of Pisa | Recruiting | Pisa | 56126 | Italy |
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| Clinica Universitaria de Podologia | Recruiting | Madrid | Spain | Spain |
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| Bradford Royal Infirmary | Recruiting | Bradford | Yorkshire | BD9 6RJ | United Kingdom |
|
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |