Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dermagraft, Profore · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement. |
| 2 | ACTIVE_COMPARATOR | Weekly application of compression dressings only, in combination with systematic surgical wound debridement. |
| Name | Type | Description |
|---|---|---|
| Dermagraft(R) | DEVICE | Weekly application of Dermagraft(R) with Profore compression as a secondary layer, in combination with systematic surgical wound debridement. |
| Profore | DEVICE | Weekly application of Profore compression dressings, in combination with systematic surgical wound debridement. |
Inclusion Criteria: * \>18 years of age * ABI \> 0.80 * Three or fewer venous leg ulcers, if multiple must be separated by 2 cm * Ultrasound demonstrates venous reflux \>0.5 seconds * Study wound present for 1-24 months * Study wound 2-15 sq cm surface area * Clean, granulating wound * Patient able...
Dermagraft is an investigational product being studied for the treatment of diabetic foot ulcers and venous leg ulcers. It is developed by Organogenesis Holdings Inc. (ORGO) and is currently in Phase 3 clinical development. Two Phase 3 trials have been completed, one for each indication.
Dermagraft is developed by Organogenesis Holdings Inc., a company traded on the stock exchange under the ticker ORGO. The company is conducting clinical trials to evaluate the product for diabetic foot ulcers and venous leg ulcers.
Dermagraft is in Phase 3 clinical development. It is not FDA approved and remains investigational. Two Phase 3 trials have been completed, one for venous leg ulcers and two for diabetic foot ulcers, with a total enrollment of 595 patients across all trials.
Dermagraft has completed three Phase 3 trials. NCT00909870 studied Dermagraft for venous leg ulcers with 537 participants. NCT01181440 and NCT01181453 studied Dermagraft for diabetic foot ulcers, enrolling 281 and 314 participants respectively. All trials are completed.
No, Dermagraft and Comparator are not the same. Dermagraft is the investigational product being studied, while Comparator refers to the control group in the clinical trials. The trials are uncontrolled, meaning they do not use a comparator arm.