Trials / Completed
CompletedNCT02675855
GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers
A Multicenter, Randomized, Single-Blind Study Comparing the Efficacy of GrafixPRIME® to Active Comparator for the Treatment of Chronic Diabetic Foot Ulcers
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Osiris Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the study is to compare the efficacy of weekly GrafixPRIME® administration to an Active Comparator in patients with chronic DFUs in a randomized, single-blind study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | GrafixPRIME® | Human tissue, Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing. |
| PROCEDURE | Dressing Application | Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing. |
| DEVICE | Off-loading (walking boot) | Patients will be fitted for an off-loading device (walking boot) and agree to comply with use of the device during the course of the study |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2017-07-01
- Completion
- 2017-07-01
- First posted
- 2016-02-05
- Last updated
- 2017-07-17
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02675855. Inclusion in this directory is not an endorsement.