Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01596920 · ClinicalTrials.gov registry record · Phase 4
Grafix® DFU: Open-Label Extension Option to Evaluate Safety & Efficacy of Grafix® for Chronic Diabetic Foot Ulcers
A Phase 4 study, sponsored by Osiris Therapeutics.
- Completed
- Registry status
- Phase 4
- Development phase
- 97
- Enrollment target
NCT01596920: Completed Phase 4 study, sponsored by Osiris Therapeutics.
NCT01596920 is a Phase 4 study that has completed, run by Osiris Therapeutics. The registered enrollment target is 97 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01596920, a Phase 4 study, has completed, sponsored by Osiris Therapeutics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 97 participants
- Enrollment target
Study Summary
The primary objective of the present study is to further establish in a randomized controlled trial, the safety and efficacy of weekly Grafix® administration versus control in patients with chronic diabetic foot ulcers. The primary endpoint is complete wound closure of the index wound, defined as 100% re-epithelialization as determined by the Investigator. Grafix® is a product regulated for use in the US by the FDA as a Human Cellular and Tissue Based Product (HCT/P) under Title 21 CFR Part 1271.
Interventions
- OTHER Control
- OTHER Tissue
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2012-04 |
| Est. Completion | 2014-03 |
| Phase | Phase 4 |
What the finished NCT01596920 record still lists
NCT01596920 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT01596920 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01596920 about?
NCT01596920 is a clinical study titled "Grafix® DFU: Open-Label Extension Option to Evaluate Safety & Efficacy of Grafix® for Chronic Diabetic Foot Ulcers". The primary objective of the present study is to further establish in a randomized controlled trial, the safety and efficacy of weekly Grafix® administration versus control in patients with chronic diabetic foot ulcers. The primary endpoint is complete wound closure of the index wound, defined as 10...
What is the current status of trial NCT01596920?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 97 participants. The study started on 2012-04. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01596920?
The interventions under investigation include: Control (OTHER), Tissue (OTHER).
Who is sponsoring clinical trial NCT01596920?
This trial is sponsored by Osiris Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01596920's enrollment target sits among peer trials
97 861st of 2000 higher than 1,138 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03948490 · 97 participants · NA
Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas
- NCT04140487 · 97 participants · Phase 1
Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm
- NCT04196413 · 97 participants · Phase 1
GD2 CAR T Cells in Diffuse Intrinsic Pontine Gliomas (DIPG) & Spinal Diffuse Midline Glioma(DMG)
- NCT05223816 · 97 participants · Phase 2
An Open-Label, Multiple-Center, Phase IIa/IIb Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of VG161 as Monotherapy and in Combination With Nivolumab for Treatment of Patients With Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia