Clinical trials: Chronic Skin Ulcers
Critical Limb Ischemia
Bone Marrow Aspirate Concentrate (BMAC) for Treatment of Critical Limb Ischemia (CLI)
Critical Limb Ischemia prevents the legs and feet from receiving oxygen and nutrients needed for proper function. This severe lack of blood flow can lead to painful legs while walking or at rest and can result in foot sores…
- Trial name
- NCT01245335
- Testing
- BMAC injection
- Where
- 34 sites in United States
- Volunteers
- 97 people
- Sponsor
- Harvest Technologies
Vascular Disease, Peripheral, Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics
The goal of this observational study is to learn if the measures of tissue oxygenation from the MIMOSA Pro imaging device correlate to standard vascular assessment tools in patients who receiving a lower extremity vascular…
- Trial name
- NCT06899113
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- MIMOSA Diagnostics Inc.
Chronic Pressure Ulcers
PuraPly® AM Plus the Standard of Care to Standard of Care Alone for the Management of Stage II-IV Pressure Ulcers.
This is a prospective, multi-center, randomized, controlled clinical study Of PuraPly® AM and standard of care (SOC) compared to SOC alone for the management of Stage II-IV pressure ulcers located in the gluteal, ischial, hip…
- Trial name
- NCT03502824
- Testing
- PuraPly® Antimicrobial Wound Matrix, SOC for Pressure Ulcers
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Organogenesis
Leg Ulcers, Leg Ulcers Venous
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Chronic lower limb ulcers, particularly those of venous etiology, are difficult-to-heal wounds that severely affect patients' quality of life. Adequate tissue oxygenation is essential for wound healing.
- Trial name
- NCT07901517
- Testing
- Vacuum Compression Therapy (VCT), Standard Wound Care
- Where
- Czechia
- Volunteers
- 20 people
- Sponsor
- BTL Industries Ltd.
Leg Ulcers
Safety Evaluation of Biatain Ibu in Painful Chronic Venous Leg Ulcers
The objective of this open label extension study (extension to study DK143WS) is to evaluate the safety of Biatain Ibu during 6 -12 weeks of exposure and during a 40 - 46 weeks safety follow-up period.
- Trial name
- NCT00628004
- Testing
- Biatain Ibu, Local best practice
- Where
- 5 sites in Denmark, Germany and 1 more
- Volunteers
- 93 people
- Sponsor
- Coloplast A/S
Diabetic Foot Ulcer
NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers
The goal of this multi-center, randomized, controlled, evaluator-blinded study is to assess and measure the safety and efficacy of NOX1416 as an adjunct to standard of care (SOC) in the treatment of chronic, non-healing, diabetic…
- Trial name
- NTCDU (NCT06402565)
- Testing
- NOX1416 and SOC, SOC (Standard of care)
- Where
- 13 sites in United States
- Volunteers
- 40 people
- Sponsor
- NOxy Health Products, LLC
Venous Leg Ulcer
Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Venous Leg Ulcers
This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Venous Leg Ulcers
- Trial name
- NCT07061613
- Testing
- NeoThelium FT (HCT/P 361)
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- NuScience Medical Biologics, LLC
Diabetic Foot Ulcer, Surgical Wound
The Effect of Natrox® Oxygen Wound Therapy on the Healing Rate of Chronic Diabetic Foot Ulcers
A Multicentre Randomized Controlled Trial to Investigate the Effect of Natrox Topical Oxygen Wound Therapy on the Healing rates of Diabetic Foot Ulcers.
- Trial name
- NCT03905863
- Testing
- Natrox® Oxygen Wound Therapy
- Where
- 20 sites in United States, Puerto Rico
- Volunteers
- 145 people
- Sponsor
- Inotec AMD Limited
Lower Extremity Chronic Ulcers in Diabetics, Diabetic Foot Ulcer (DFU)
Artacent Amniotic Tissue for Treatment of Chronic Lower Extremity Diabetic Ulcers.
This is study is to determine if A tri-layered dehydrated human amnion/chorion/amnion composite graft would help non-healing lower extremity diabetic ulcers to heal over a 12 week time period.
- Trial name
- NCT07219004
- Testing
- amniotic membrane
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Tides Medical
Diabetic Foot
Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
The primary objective of this study is to evaluate the efficacy of the new treatment of WH-1 ointment compared to Aquacel® Hydrofiber® dressing, applied to chronic diabetic foot ulcers for up to 16 weeks.An additional objective…
- Trial name
- NCT01898923
- Testing
- ON101 Cream, Aquacel® Hydrofiber® dressing
- Where
- 21 sites in United States, China and 1 more
- Volunteers
- 236 people
- Sponsor
- Oneness Biotech Co., Ltd.
Diabetic Foot
The Pharmacokinetic Study of WH-1 Ointment in Subjects With Chronic Diabetic Foot Ulcers
The objective of this study is to evaluate the systemic exposures of WH-1 ointment which includes Salvigenin and Asiaticoside A in subjects with chronic diabetic foot ulcers following topical application of WH-1.
- Trial name
- NCT02353273
- Testing
- WH-1 ointment
- Where
- Taiwan
- Volunteers
- 12 people
- Sponsor
- Oneness Biotech Co., Ltd.
Diabetic Foot Ulcer
A Dose Finding Study of Topically Applied I-020201 as an Adjunct to Good Standard-of-care in Patients With Chronic Diabetic Foot Ulcers
Although major improvements in the management and treatment of diabetic foot ulcers have been made, the clinical and financial burden of such long-term wounds is still high and is likely to increase as the general population…
- Trial name
- DFU (NCT00915486)
- Testing
- Good Standard of Care (GSoC), Vehicle, I-020201
- Where
- 34 sites in Czechia, Germany and 4 more
- Volunteers
- 211 people
- Sponsor
- Kuros Biosurgery AG
Skin Ulcer, Pressure Ulcer (PU)
Study Title: A Multicenter, Prospective, Modified Platform Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Matched Standard of Care Controls in the Management of Nonhealing Pressure Ulcers.
A multicenter prospective modified platform trial evaluating several cellular, acellular, and matrix like products and standard of care versus matched standard of care controls in the management of nonhealing pressure ulcers.
- Conditions
- Skin Ulcer, Pressure Ulcer (PU), Pressure Ulcer of Skin, Pressure Sore
- Trial name
- RESTORE (NCT07665268)
- Testing
- Activate™ Matrix + SOC, AmnioDefend™ FT Matrix + SOC, Palisade™ DM Matrix + SOC
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Sequence LifeScience, Inc.
Venous Leg Ulcer (VLU)
Trial to Evaluate Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Venous Leg Ulcers
The purpose of this study is to evaluate the efficacy, safety and economic benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of venous leg ulcers.
- Trial name
- VaLUe I (NCT06754735)
- Testing
- Topical Wound Oxygen Therapy
- Where
- United States
- Volunteers
- 212 people
- Sponsor
- AOTI Ltd.
Peptic Ulcer
Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers
The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.
- Trial name
- NCT00450658
- Testing
- HZT-501, Ibuprofen
- Volunteers
- 627 people
- Sponsor
- Amgen
Pressure Ulcers, Venous Ulcers
Prospective PuraPly™ AM Case Series Study
The PuraPly AM case series is a prospective, observational study for patients who have received PuraPly AM which consists of a collagen sheet coated with polyhexamethylene biguanide hydrochloride (PHMB) and is intended for the…
- Conditions
- Pressure Ulcers, Venous Ulcers, Diabetic Ulcers, Surgical Wounds
- Trial name
- NCT03070925
- Testing
- PuraPly™ Antimicrobial Wound Matrix
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Organogenesis
Platelet-Derived Growth Factor, Diabetic Foot
Evaluation of the Safety Follow-up of Becaplermin or Placebo Gel Following Treatment of Chronic, Full Thickness Diabetic Ulcers
The purpose of this study is to retrospectively evaluate the safety of sterile becaplermin gel compared with sterile placebo gel treatment 12 months or more after the last dose was administered in 1 of 2 double-blind trials…
- Conditions
- Platelet-Derived Growth Factor, Diabetic Foot, Neoplasms
- Trial name
- NCT00740922
- Volunteers
- 563 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Diabetic Foot Ulcers (DFUs), Diabetic Foot
Miro3D Wound Matrix for Treatment of Diabetic Foot Ulcers
This study is designed to evaluate whether the Miro3D Wound Matrix, when used in addition to standard of care, improves healing outcomes in patients with chronic diabetic foot ulcers.
- Conditions
- Diabetic Foot Ulcers (DFUs), Diabetic Foot, Chronic Wounds
- Trial name
- FOCUS 3D (NCT07632001)
- Testing
- Miro3D Wound Matrix, Standard of Care
- Where
- 14 sites in United States
- Volunteers
- 180 people
- Sponsor
- Reprise Biomedical, Inc.
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
Wounds and Injuries, Burns
Clinical Registry Collecting Real World Evidence on Wound Care Treatments
The proposed registry Sponsor (Siddhey LLC) will collect data on various wound treatments in real life settings. Data collection will facilitate the analysis of the safety and efficacy of wound treatments.
- Conditions
- Wounds and Injuries, Burns, Mohs Surgery, Diabetic Foot Ulcer Mixed
- Trial name
- SIDDX (NCT06328010)
- Testing
- Various types of wound care treatments
- Where
- 12 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- Siddhey LLC