Clinical trials: Leg Ulcers
Diabetic Foot Ulcer
Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers
The purpose of this clinical trial is to evaluate the safety and effectiveness of the treatment with the COMS One device in subjects with refractory diabetic foot ulcers (DFUs).
- Trial name
- Mavericks (NCT05758545)
- Testing
- COMS One device
- Where
- 30 sites in United States
- Volunteers
- 450 people
- Sponsor
- Piomic Medical
Diabetic Foot Ulcer (DFU), Chronic Foot Ulcers
Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers
The purpose of this clinical investigation is to evaluate the safety and efficacy of Amnion/Chorion/Amnion allograft , Amnion/Chorion allograft, and/or Amnion/Amnion allograft, plus Standard of Care (SOC) each versus SOC alone in…
- Trial name
- NCT06681428
- Testing
- Allograft
- Where
- 9 sites in United States
- Volunteers
- 240 people
- Sponsor
- Tides Medical
Foot Ulcer, Diabetic, Diabetic Foot
Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers
The purpose of this study is to assess if the experimental drug, DSC127, is safe, how well it can be tolerated, and how different doses effect the healing of the chronic foot ulcers in diabetic subjects.
- Trial name
- NCT00796744
- Testing
- NorLeu3-A(1-7) in a gel formulation
- Where
- 12 sites in United States
- Volunteers
- 78 people
- Sponsor
- US Biotest, Inc.
Venous Leg Ulcer
Human Amniotic Membrane Grafting and Standard of Care Versus Standard of Care Alone in the Treatment of Venous Leg Ulcers
The purpose of this study is to determine whether the EpiFix human amniotic membrane is effective in the treatment of venous leg ulcers.
- Trial name
- NCT01552447
- Testing
- EpiFix, Compression Therapy
- Where
- 5 sites in United States
- Volunteers
- 98 people
- Sponsor
- MiMedx Group, Inc.
Venous Stasis Ulcer
A Multi-center, Prospective, Randomized Study With PriMatrix and PriMatrix Ag for the Treatment of Venous Leg Ulcers
To evaluate the effectiveness of PriMatrix, PriMatrix Ag, and Standard of Care in the treatment of venous leg ulcers (VLUs).
- Trial name
- NCT01612806
- Testing
- PriMatrix, PriMatrix Ag, moist wound therapy
- Where
- 5 sites in Puerto Rico
- Volunteers
- 31 people
- Sponsor
- Integra LifeSciences Corporation
Burn, Trauma
Trial of Zesteem (Estradiol) in Healing of Split Thickness Skin Graft Donor Sites
This trial will assess the effects of Zesteem (estradiol) on the healing of split thickness skin graft donor sites in patients aged 18-85 years.
- Conditions
- Burn, Trauma, Varicose Ulcer
- Trial name
- NCT00426972
- Testing
- estradiol (Zesteem)
- Where
- 30 sites in Germany, Latvia and 2 more
- Volunteers
- 148 people
- Sponsor
- Renovo
Critical Limb Ischemia
Autologous Adipose-Derived Stromal Cell Delivered Via Intramuscular Injections for the Treatment of Critical Limb Ischemia
This is an open-label, non-randomized, multi center, patient sponsored study of Adipose-Derived Stromal Cell (ASC) implantation via intramuscular injections in patients who have critical limb ischemia not amenable for…
- Trial name
- NCT02099500
- Testing
- Liposuction, Stem Cell Injection
- Where
- United States
- Sponsor
- Ageless Regenerative Institute
Venous Leg Ulcer
Study to Evaluate Safety and Efficacy of GrafixPL for the Treatment of Venous Leg Ulcers
A Multicenter, Prospective, Randomized, Open-Label Study with a Crossover Extension Option to Evaluate the Safety and Efficacy of GrafixPL for the Treatment of Chronic VLUs
- Trial name
- NCT03629236
- Testing
- GrafixPL, Control
- Where
- 2 sites in United States
- Volunteers
- 200 people
- Sponsor
- Osiris Therapeutics
Diabetic Foot Ulcer
Comparative Study of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers
The purpose of this study is to determine whether the EpiFix human amniotic membrane is effective in the treatment of diabetic foot ulcers.
- Trial name
- NCT01552499
- Testing
- Standard of care, Applications of EpiFix
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- MiMedx Group, Inc.
Foot Ulcer, Diabetes
Safety and Efficacy Study of an Interactive Wound Dressing (KC002) for the Treatment of Diabetic Foot Ulcers
The objective of this study is to determine the safety and effectiveness of a device (the KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as compared with a conventional wound therapy…
- Trial name
- KC-002PT (NCT00330265)
- Testing
- KC-002, Conventional Wound Therapy
- Where
- 21 sites in United States
- Volunteers
- 300 people
- Sponsor
- KeraCure
Venous Leg Ulcer (VLU)
A Multicenter, Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of a Soft Silicone Foam Dressing and to Evaluate the Performance of Standard Care in Exuding Venous Leg Ulcers
This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of Mölnlycke Health Care's quality system.
- Trial name
- NCT02167815
- Testing
- Mepilex XT, standard care
- Where
- 3 sites in Czechia
- Volunteers
- 30 people
- Sponsor
- Molnlycke Health Care AB
Ulcers
A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Venous Leg Ulcers
This is a Phase II, randomized, controlled, two-center pilot study designed to assess the safety and efficacy of MEBO in the treatment of 14 subjects with VLUs.
- Trial name
- NCT01138436
- Testing
- MEBO Wound Ointment (MEBO), Standard of Care
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Skingenix, Inc.
Diabetic Foot Ulcers, Pressure Ulcers
Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds
To compare HP828-101 to standard of care for the management of partial or full thickness wounds
- Trial name
- NCT00971048
- Testing
- HP828-101, Hydrogel/Hydrocolloid
- Where
- 11 sites in United States
- Volunteers
- 88 people
- Sponsor
- Healthpoint
Diabetic Foot Ulcers
A Pilot Study of the Provant Therapy System in Subjects With Diabetic Foot Ulcers
The objective of this study is to compare the reduction in wound surface areas between patients with diabetic ulcers utilizing Provant's pulsed radio frequency energy therapy (PRFE) as an adjunct to standardized basic wound care…
- Trial name
- NCT00761176
- Testing
- The Provant Therapy System
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Regenesis Biomedical, Inc.
Peripheral Arterial Disease, Diabetic Foot Ulcer
Study of PDA-002 in Subjects With Peripheral Arterial Disease and Diabetic Foot Ulcers
This Phase 1, multicenter, open-label, dose-escalation study evaluated the safety and tolerability of intramuscular administration of PDA-002 (human placenta-derived cells) in subjects with peripheral arterial disease (PAD) and…
- Trial name
- NCT01859117
- Testing
- PDA-002
- Where
- 12 sites in United States
- Volunteers
- 15 people
- Sponsor
- Celularity Incorporated
Diabetic Foot Ulcers
dHACM Mesh In the Treatment of Diabetic Foot Ulcers
A single-centered, non-randomized study with approximately 20 subjects that will be seen for up to 12 weeks, each receiving the EpiFix mesh plus standard of care. Safety and effectiveness will be monitored throughout the study.
- Trial name
- NCT02589210
- Testing
- EpiFix Mesh
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- MiMedx Group, Inc.
Diabetic Foot Ulcer, Venous Ulcer
Wound Healing Effects of HO/03/03 In Patients With Diabetic Neuropathic Plantar and Venous Ulcers, Pilot Study.
This is a multicenter pilot study to assess the healing effects of HO/03/03 on diabetic neuropathic plantar and venous ulcers. HO/03/03 action mechanism involves the manipulation of keratinocyte and fibroblast migration and…
- Trial name
- NCT00338923
- Testing
- HO/03/03
- Where
- 3 sites in Israel
- Volunteers
- 22 people
- Sponsor
- HealOr
Critical Limb Ischemia, Peripheral Vascular Disease
Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures
The purpose of this study is to assess and compare the safety of continuous and daily subcutaneous Remodulin therapy in patients with critical limb ischemia (CLI) with no planned vascular interventional procedures; and to…
- Conditions
- Critical Limb Ischemia, Peripheral Vascular Disease, Foot Ulcers, Rest Leg Pain
- Trial name
- NCT00060996
- Testing
- Remodulin® (treprostinil sodium) Injection
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- United Therapeutics
Diabetic Foot Ulcers
A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)
The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with diabetic foot ulcers (DFUs).
- Trial name
- NCT01154374
- Testing
- MEBO Wound Ointment, Standard of Care (sterile saline moistened gauze)
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Skingenix, Inc.
Venous Leg Ulcer
Evaluation of Pain Associated With the Removal of Wound Dressing During Care of Venous Leg Ulcer. Comparison of the Efficacy and Safety of Two Dressings Urgotul and TulleGras
Evaluation of the non-inferiority of TulleGras M.S.® versus Urgotul® in pain associated with removal of wound dressing during care of venous leg ulcer
- Trial name
- NCT02104180
- Testing
- Urgotul, TulleGras M.S.
- Where
- 27 sites in France
- Volunteers
- 62 people
- Sponsor
- Mylan Inc.