4 unknown, 3 terminated, 2 completed, 1 withdrawn. 4 Phase 4, 1 Not applicable, 1 Phase 1, 1 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 4 | Completed 1, Terminated 1, Unknown 1, Withdrawn 1 |
| Not applicable | 1 | Terminated 1 |
| Phase 1 | 1 | Completed 1 |
| Phase 2 | 1 | Completed 1 |
| Phase 3 | 1 | Terminated 1 |
Follow Apligraf: new trials by email Literature Review of Apligraf trials Research Report on Apligraf
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU) Synthetic Hybrid-Scale Fiber Matrix, Standard of Care, Living Cellular Skin Substitute - Diabetic Foot Ulcer, Venous Leg Ulcer | Not applicable | Terminated | Acera Surgical, Inc. | 48 | 2021-07-19 | 2026-02-27 |
| Venous Leg Ulcer and Lymphedema Registry cellular and tissue based therapy, debridement, advanced wound therapy - Venous Stasis Ulcer, Quality of Patient Care | Unknown | U.S. Wound Registry | 10000 | 2016-05-01 | 2018-04-25 | |
| The Diabetic Foot Ulcer Registry cellular and tissue based therapy, negative pressure wound therapy, debridement - Diabetic Foot Ulcer Outcome, Quality of Patient Care | Unknown | U.S. Wound Registry | 10000 | 2015-02-01 | 2018-05-03 | |
| A Study Of Pain And Quality Of Life Outcomes In Subjects With a Single Painful Venous Leg Ulcer Treated With Apligraf® Apligraf - Venous Leg Ulcers | Phase 4 | Unknown | Organogenesis | 100 | 2013-11-01 | 2013-12-13 |
| A Observational Study to Evaluate Apligraf(R) in Nonhealing Wounds of Subjects With Epidermolysis Bullosa Apligraf - Epidermolysis Bullosa, Wound Healing | Phase 4 | Terminated | University Hospital, Basel, Switzerland | 3 | 2012-06-01 | 2015-03-10 |
| A Post Marketing Study of Apligraf in Non-healing Wounds of Subjects With Venous Leg Ulcers Apligraf, Standard of Care Dressing Group - Venous Ulcer | Phase 4 | Completed | Organogenesis | 30 | 2011-03-01 | 2015-09-24 |
| A Post-Marketing Clinical Study of Apligraf for Venous Leg Ulcers Apligraf - Varicose Ulcer | Phase 4 | Withdrawn | Organogenesis | 2008-07-01 | 2015-08-19 | |
| A Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids Apligraf, Standard dressing regimen - Keloid | Phase 1 / Phase 2 | Completed | Organogenesis | 30 | 2007-12-01 | 2011-08-19 |
| Safety and Efficacy of Apligraf in Nonhealing Wounds of Subjects With Junctional or Dystrophic Epidermolysis Bullosa (EB) Apligraf, Standard dressing regimen - Epidermolysis Bullosa, Junctional, Epidermolysis Bullosa Dystrophica | Phase 3 | Terminated | Organogenesis | 1 | 2007-12-01 | 2010-06-29 |
| Cellular and Tissue Based Therapy Registry Cellular and tissue based products - Diabetic Foot Ulcers, Venous Stasis Ulcer | Unknown | U.S. Wound Registry | 50000 | 2005-01-01 | 2018-05-01 |
Varicose Ulcer (5) · Diabetic Foot (3) · Wounds and Injuries (2) · Diabetes Mellitus (1) · Epidermolysis Bullosa (1) · Epidermolysis Bullosa Dystrophica (1) · Epidermolysis Bullosa, Junctional (1) · Keloid (1) · Lymphedema (1) · Pressure Ulcer (1) · Surgical Wound Dehiscence (1)
Organogenesis (5) · U.S. Wound Registry (3) · Acera Surgical, Inc. (1) · University Hospital, Basel, Switzerland (1)
United States (8) · Switzerland (1)
Damien Bates, MD, PhD, FRACS (Plast.) (3) · Andreas Arnold, MD (1) · David G. Armstrong, DPM, MD, PhD (1) · Elizabeth Alvarez- Connelly, MD (1) · Evangelos Badiavas, MD, PhD (1) · Heather Woolery-Lloyd, MD (1) · Scott Gorenstein, MD (1) · William A. Marston, MD (1)