Clinical trials: Chronic Ulcer of Lower Extremity
Diabetic Foot Ulcer (DFU)
Controlled Trial to Evaluate the Safety and Efficacy of CYWC628 (Human Dermal Fibroblast Spheroids) for the Treatment of Refractory Diabetic Foot Ulcers Compared With Standard of Care
This is a prospective, multicentre, randomized clinical trial evaluating the safety, tolerability, and efficacy of up to 12 weeks treatment with SoC + low- or high-dose CYWC628 in treating DFU, compared to SoC only.
- Trial name
- NCT07096934
- Testing
- Standard of Care (SOC), SoC + Low dose CYWC628, SoC + High dose CYWC628
- Where
- 9 sites in Australia
- Volunteers
- 120 people
- Sponsor
- FibroBiologics
Chronic Ulcer of Lower Extremity
Plasma On Chronic Wounds for Epidermal Regeneration
Every year, 5 million people throughout Germany suffer from extensive, often chronic wounds. Cold plasma is an innovative therapeutic approach in the treatment of these persistent tissue defects.
- Trial name
- POWER (NCT05855499)
- Testing
- CPtcube, CPTpatch
- Where
- 8 sites in Germany
- Volunteers
- 120 people
- Sponsor
- Coldplasmatech
Chronic Venous Leg Ulcers
Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy
Indication: Subjects with chronic venous leg ulcers Primary Objective: To evaluate the efficacy of bio-electrical stimulation therapy in the healing of chronic venous leg ulcers Secondary Objective(s): To evaluate the percentage…
- Trial name
- NCT00678847
- Testing
- KFH NOVO (inactive) + SCT, KFH Novo (BEST) + SCT
- Where
- Belgium
- Volunteers
- 50 people
- Sponsor
- Kingfisher Healthcare
Diabetic Foot, Pressure Ulcer
A Real-World Registry of Chronic Wounds and Ulcers
WOUNDJOURNEY is a longitudinal, real-world, observational registry designed to capture the full clinical course and patient journey associated with chronic wounds and ulcers.
- Conditions
- Diabetic Foot, Pressure Ulcer, Surgical Wound Dehiscence, Vasculitis
- Trial name
- WOUNDJOURNEY (NCT02280733)
- Testing
- Usual care
- Where
- United States
- Volunteers
- 300,000 people
- Sponsor
- U.S. Wound Registry
Diabetic Foot Ulcer, Diabetic Foot
Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery
Despite the development of the control of DM and the great interest for the complications of the disease, even today the diabetic foot represents a challenge for the orthopaedic surgeon.
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot, Diabetic Foot Infection, Diabetic Foot Ulcer Neuropathic
- Trial name
- DiabeticMIS1 (NCT03010215)
- Testing
- Distal Metatarsal Minimally invasive Osteotomy (DMMO)
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- University of Padova
Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
Transcutaneous Application of Gaseous CO2
The research is designed to evaluate influence of transcutaneous application of CO2 (carbon dioxide) on chronic wound healing. Transcutaneous application of CO2 is known to have immediate effect on vasodilatation and elevates…
- Trial name
- NCT04561609
- Testing
- Transcutaneous CO2 application
- Where
- 3 sites in Croatia, Slovenia
- Volunteers
- 120 people
- Sponsor
- University Medical Centre Ljubljana
Lower Extremity, Chronic Ulcers
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers
To prospectively evaluate the safety and efficacy of an Autologous Platelet-Rich Fibrin Plasma system when applied in conjunction with Standard of Care for management of chronic lower extremity wounds.
- Conditions
- Lower Extremity, Chronic Ulcers, Pressure Ulcer (PU), Venous Leg Ulcer (VLU)
- Trial name
- NCT07862335
- Testing
- PRFM
- Volunteers
- 30 people
- Sponsor
- Tiger Biosciences, LLC.
Diabetes Mellitus, Claudication, Intermittent
Additional Hyperbaric Oxygen After Lower Extremity Amputation
This study evaluates the effect of additional hyperbaric oxygen therapy after lower extremity amputation. The patients will be randomized after amputation to either a treatment group receiving hyperbaric oxygen therapy, or…
- Conditions
- Diabetes Mellitus, Claudication, Intermittent, Critical Limb Ischemia, Osteomyelitis
- Trial name
- AHOLEA (NCT03594344)
- Testing
- Hyperbaric oxygen therapy
- Where
- 2 sites in Norway
- Volunteers
- 120 people
- Sponsor
- Oslo University Hospital
Diabetic Foot Ulcer, Venous Ulcer
Enhanced Ultrasound Treatment of Chronic Wounds With Monitoring of Healing and Quality of Life Outcomes
The purpose of this study is to evaluate the effect of low frequency, low intensity ultrasound treatment on wound healing and health-related quality of life with a randomized clinical trial of patients with venous ulcers or…
- Trial name
- NCT03041844
- Testing
- Low Frequency, Low Intensity Ultrasound
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Drexel University
Leg Ulcer, Pain
Pain in Chronic Leg- and Foot Ulcers
Leg ulcers are a significant cause of impaired functional ability and quality of life for approximately 1-2 percent of the population in western countries.
- Trial name
- NCT03086577
- Where
- Norway
- Volunteers
- 360 people
- Sponsor
- University College of Southeast Norway
Chronic Leg Ulcer, Chronic Diabetic Foot Ulcer
A PMCF Investigation on Chronic LU and DFU in Need of Debridement With ChloraSolv®
This is a single-arm, observational, multicenter PMCF investigation designed to confirm clinical performance and safety of ChloraSolv when exposed to larger population of clinical users.
- Trial name
- ChloraSolv02 (NCT04838600)
- Testing
- ChloraSolv
- Where
- 7 sites in Sweden
- Volunteers
- 34 people
- Sponsor
- RLS Global
Diabetic Foot Ulcer, Venous Leg Ulcer
DETEC® pH Point of Care Wound Diagnostic Test
The purpose of this study is to determine the relationship between wound alkalinity and the non-healing status of chronic ulcer wounds.
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Wound, Non-Healed
- Trial name
- NCT04614038
- Testing
- DETEC® pH
- Where
- 2 sites in United States
- Volunteers
- 450 people
- Sponsor
- Progenitec Inc.
Leg Ulcers, Diabetic Foot Ulcer
Vacuum Compression Therapy for Chronic Lower Limb Ulcers
The goal of this clinical trial is to learn if vacuum compression therapy added to standard care improves wound healing in adults with chronic lower limb ulcers.
- Conditions
- Leg Ulcers, Diabetic Foot Ulcer, Varicose Ulcers, Skin Ulcer
- Trial name
- NCT07737184
- Testing
- Vacuum Compression Therapy (VCT), Standardized Wound Care
- Where
- Czechia
- Volunteers
- 50 people
- Sponsor
- BTL Industries Ltd.
Venous Leg Ulcer (VLU), Chronic Wound
Smart Bandage With Telemonitoring vs Standard Care for Venous Leg Ulcer: Randomized Trial
Venous leg ulcers (VLUs) are chronic wounds that are often slow to heal and can greatly affect patients' daily lives. This study will evaluate a new "smart bandage" that can monitor wound conditions such as pH, temperature, and…
- Trial name
- SMART-VLU (NCT07163195)
- Testing
- Smart Bandage with Telemonitoring, Conventional Bandage
- Where
- Indonesia
- Volunteers
- 110 people
- Sponsor
- Asmat Burhan
Diabetic Foot Ulcer, Non-healing Wound
An Observational Clinical Trial Examining the Effect of Topical Oxygen Therapy (NATROX™) on the Rates of Healing of Chronic Diabetic Foot Ulcers
This study aims to evaluate the effectiveness of NATROX™ Topical Oxygen Wound Therapy for subjects with non-healing foot ulceration. Subjects will be treated with standard care for 4 weeks.
- Trial name
- NCT03863054
- Testing
- NATROX™ Topical Oxygen Therapy System
- Where
- Singapore
- Volunteers
- 20 people
- Sponsor
- Singapore General Hospital
Chronic Leg Ulcer, Venous Leg Ulcer
Safety and Tolerability of Single and Multiple Doses of SoftOx Biofilm Eradicator (SBE) in Chronic Leg Wounds
Single-centre clinical study investigating the safety and tolerability of randomised, double-blinded, placebo-controlled ascending single doses of topically applied SoftOx Biofilm Eradicator (SBE) in patients with chronic leg…
- Trial name
- NCT05710094
- Testing
- SoftOx Biofilm Eradicator (Groups 1 to 7), Sterile isotonic saline (Groups 1 to 4)
- Where
- Denmark
- Volunteers
- 28 people
- Sponsor
- SoftOx Solutions AS
Chronic Ulcers: Non-healing Deep Cavity Wounds (e.g., Diabetic Foot Ulcers, Arterial Ulcers, Post-surgical Wound Healing Disorders)
INJECTHEAL - Investigation of Chronic Wound Exudate and Biofilm
This prospective observational study will collect routine clinical waste material from 72 adults with chronic, non-healing wounds, including wound exudate from negative pressure therapy containers or sponges and wound…
- Trial name
- INJECTHEAL (NCT07745764)
- Testing
- standard of care
- Where
- Germany
- Volunteers
- 72 people
- Sponsor
- Barbara Wolff-Winiski
Wound
Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border
The clinical study will evaluate the safety and effectiveness of the ALLEVYN Gentle Border. The study is a post-market clinical follow-up to assess clinical performance and safety of ALLEVYN Gentle Border with new wound contact…
- Trial name
- NCT03877484
- Testing
- ALLEVYN Gentle border
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 43 people
- Sponsor
- Smith & Nephew Orthopaedics AG
Chronic Ulcer of Leg or Foot, Diabetic Foot Ulcer
MAtrix Therapy for Hard-to-heal ChrOnic Wounds
CACIPLIQ20® is currently a class III CE marked medical device available in various European and non-European countries, and currently primarily used in managing hard-to-heal wounds.
- Conditions
- Chronic Ulcer of Leg or Foot, Diabetic Foot Ulcer, Arterial Ulcer, Venous Ulcer of Leg
- Trial name
- MATHCOW (NCT05170984)
- Testing
- CACIPLIQ20®
- Where
- France
- Volunteers
- 191 people
- Sponsor
- Organ, Tissue, Regeneration, Repair and Replacement
Diabetic Foot Ulcer, Wagner Grade 1 - 2
Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers
ELU42 01 01 (SuperHealer42) is a Phase I/IIA open label study sponsored by Eluciderm, Inc. that evaluates the safety and preliminary effectiveness of ELU42, a topical small molecule designed to modulate Wnt signaling, for the…
- Conditions
- Diabetic Foot Ulcer, Wagner Grade 1 - 2, Chronic Wound, Open Wound
- Trial name
- NCT07396376
- Testing
- ELU42 Topical Spray
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Eluciderm Inc