4 completed, 3 terminated, 2 recruiting, 1 not yet recruiting. 11 Phase 2, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 11 | Completed 4, Terminated 3, Recruiting 2, Not yet recruiting 1, Unknown 1 |
| Phase 1 | 1 | Recruiting 1 |
Follow digital ulcers: new trials by email Literature Review of digital ulcers trials Research Report on digital ulcers
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 |
|---|---|---|---|---|---|---|
| Efficacy and Safety Study of L608 in Patients With Systemic Sclerosis-associated Digital Ulcers L608, Placebo - Systemic Sclerosis | Phase 2 | Not yet recruiting | Pharmosa Biopharm Inc. | 40 | 2027-02-01 | 2026-11-09 |
| Safety and Tolerability of TOP-N53 Applied on Digital Ulcers in Patients With Systemic Sclerosis TOP-N53, Sildenafil, TOP-N53 vehicle - Digital Ulcers in Systemic Sclerosis | Phase 2 | Recruiting | Topadur Pharma AG | 15 | 2025-02-04 | 2026-10-01 |
| Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis Mesenchymal stromal cells, Placebo - Systemic Sclerosis, Digital Ulcer | Phase 1 / Phase 2 | Recruiting | UMC Utrecht | 20 | 2021-10-06 | 2025-09-10 |
| Effect and Safety of Local Injection of Botulinum Toxin Type B Against Digital Ulcer in Systemic Sclerosis Botulinum toxin type B (2500 units / vial), Physiological saline - Systemic Sclerosis Patients With Digital Ulcers | Phase 2 | Completed | Gunma University | 10 | 2016-12-12 | 2020-05-14 |
| Riociguat in Scleroderma Associated Digital Ulcers Riociguat, Placebo - Scleroderma, Digital Ulcers | Phase 2 | Completed | Dinesh Khanna, MD, MS | 17 | 2016-09-01 | 2019-09-24 |
| CSL Behring Sclero XIII Fibrogammin®P, coagulation factor XIII concentrate (Human), 0.9% sodium chloride - Systemic Sclerosis | Phase 2 | Unknown | University College, London | 26 | 2015-09-01 | 2016-05-30 |
| Open-Label Study of Oral Treprostinil in Digital Ulcers treprostinil diethanolamine - Systemic Sclerosis | Phase 2 | Terminated | United Therapeutics | 115 | 2009-09-01 | 2024-06-18 |
| Safety and Efficacy Study of MRE0094 to Treat Large, Single or Multiple, Chronic, Neuropathic, Diabetic Foot Ulcers MRE0094, Vehicle gel - Foot Ulcer, Diabetic, Diabetes Complications | Phase 2 | Terminated | Pfizer | 16 | 2006-06-01 | 2012-06-01 |
| Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers MRE0094 - Foot Ulcer, Diabetic, Diabetes Complications | Phase 2 | Completed | Pfizer | 322 | 2005-12-01 | 2012-06-01 |
| Sildenafil for Treatment of Digital Ulcers in Patients With Systemic Sclerosis Sildenafil therapy - Active Digital Ulcers | Phase 2 | Completed | Charite University, Berlin, Germany | 17 | 2004-02-01 | 2009-01-07 |
| Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis iloprost, iloprost low dose, iloprost therapy up to 2 ng/kg x min - Systemic Sclerosis | Phase 2 | Terminated | Charite University, Berlin, Germany | 50 | 1997-09-01 | 2008-02-25 |
Scleroderma, Systemic (7) · Scleroderma, Diffuse (3) · Diabetes Complications (2) · Diabetic Foot (2) · Foot Ulcer (2) · Vascular Diseases (2) · Raynaud Disease (1)
Skin Diseases (10) · Skin and Connective Tissue Diseases (10) · Connective Tissue Diseases (8) · Cardiovascular Diseases (5) · Vascular Diseases (3) · Diabetes Mellitus (2) · Diabetic Angiopathies (2) · Diabetic Neuropathies (2) · Endocrine System Diseases (2) · Foot Diseases (2) · Leg Ulcer (2) · Skin Ulcer (2) · Embolism and Thrombosis (1) · Livedoid Vasculopathy (1) · Peripheral Vascular Diseases (1)
2-(2-(4-chlorophenyl)ethoxy)adenosine (2) · Factor VIII (1) · Factor XIII (1) · Iloprost (1) · Saline Solution (1) · Sildenafil Citrate (1) · Sodium Chloride (1) · batrachotoxinin A 20-alpha-benzoate (1) · rimabotulinumtoxinB (1) · riociguat (1) · treprostinil (1)
Charite University, Berlin, Germany (2) · Pfizer (2) · Dinesh Khanna, MD, MS (1) · Gunma University (1) · Pharmosa Biopharm Inc. (1) · Topadur Pharma AG (1) · UMC Utrecht (1) · United Therapeutics (1) · University College, London (1)
United States (4) · Germany (2) · United Kingdom (2) · Canada (1) · France (1) · Japan (1) · Netherlands (1) · Switzerland (1)
Christopher Denton, PhD (1) · Dinesh Khanna, MD (1) · Dr. Gabriela Riemekasten, MD (1) · Gabriela Riemekasten, MD (1) · James Seibold, MD (1) · Marianne Verhaar, MD, PhD (1) · Robert L. Rolleri, Pharm.D. (1) · Sei-ichiro Motegi (1)
PMID 18634152, PMID 30127049, PMID 31481106
2014 (1), 2015 (1)