Clinical trials: Leg Injuries and Disorders
Venous Leg Ulcer
Investigation to Evaluate the Efficacy and Safety of Exufiber Versus Aquacel Extra in Moderately or Strongly Exuding Venous and Mixed Ulcers of Predominantly Venous Origin
The investigation is designed as an open, randomized, non-inferiority, multi-centre investigation. 212 evaluable subjects will be randomised.
- Trial name
- PD-497314 (NCT02921750)
- Testing
- Exufiber Gelling Fibre Dressing, Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre
- Where
- 33 sites in Czechia, Denmark and 4 more
- Volunteers
- 248 people
- Sponsor
- Molnlycke Health Care AB
Chronic Wounds, Venous Leg Ulcer (VLU)
Evaluation of Cold Plasma in Chronic Wound Healing
The goal of this clinical trial is to evaluate the effectiveness of cold atmospheric plasma treatment in promoting the healing of chronic wounds in adult participants suffering from chronic wounds.
- Conditions
- Chronic Wounds, Venous Leg Ulcer (VLU), Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
- Trial name
- PLASANAGENESIS (NCT06964048)
- Testing
- Cold Atmospheric Plasma treatment
- Volunteers
- 66 people
- Sponsor
- Plasana Medical
Diabetic Foot Ulcers
Hyperspectral Imaging to Assess and Predict Diabetic Foot Ulcers
This study is designed to test a prototype imaging instrument that relies on Medical HyperSpectral Imaging (MHSI) technology for the assessment and prediction of diabetic foot ulceration and wound healing.
- Trial name
- NCT00617916
- Where
- 3 sites in United States
- Volunteers
- 256 people
- Sponsor
- HyperMed
Venous Ulcer
Silica Gel Fiber Wound Dressing for Chronic Venous Leg Ulcers
Silica Gel Fiber is a bioresorbable, inorganic silica gel fibre patch promoting skin tissue growth and enhanced wound healing for all types of chronic wounds.
- Trial name
- NCT00998673
- Testing
- Silica Gel Fiber, Standard-of-Care
- Where
- 14 sites in Germany
- Volunteers
- 121 people
- Sponsor
- Bayer
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.
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.
Osteoarthritis of the Knee, Degenerative Osteoarthritis
Platelet-Rich Plasma and the Effects of NSAIDs on Pain and Functional Scores in Knee Osteoarthritis
The primary research purpose is to determine if the use of a drug therapy intervention (each study participant will be randomly assigned to receive one of 3 study medications which will be blinded from everyone, including the…
- Conditions
- Osteoarthritis of the Knee, Degenerative Osteoarthritis, Knee Pain Chronic
- Trial name
- PRPNSAIDsKOA (NCT05742763)
- Testing
- Ibuprofen and PRP, Acetaminophen and PRP
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- QC Kinetix LLC
Osteoarthritis, Avascular Necrosis
PMCF Study of the CLS Brevius Stem With Kinectiv Technology
This study is a multi-center, prospective, non-controlled post-market surveillance study. The primary objective of this study is to confirm the safety and performance of the CLS Brevius stem with Kinectiv technology by obtaining…
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Femoral Neck Fractures
- Trial name
- NCT03410940
- Testing
- CLS Brevius stem with Kinectiv technology
- Where
- 4 sites in Italy, Poland and 1 more
- Volunteers
- 223 people
- Sponsor
- Zimmer Biomet
Sarcopenia in Elderly, Frailty
Safety and Efficacy of Isomyosamine in Reducing Inflammation and Treating Muscle Loss in Older Adults After Hip or Thigh Bone Fractures
This Phase II clinical study investigates the safety and effectiveness of a new drug, Isomyosamine, in patients with sarcopenia or frailty, conditions associated with aging and muscle weakness.
- Conditions
- Sarcopenia in Elderly, Frailty, Frailty/Sarcopenia, Frailty in Older Adults
- Trial name
- NCT06942182
- Testing
- Isomyosamine 250mg
- Volunteers
- 60 people
- Sponsor
- TNF Pharmaceuticals, Inc.
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
Diabetic Foot Ulcer
Prospective, Multicenter, RCT of the Tenex Ultrasound System
The goal of this multicenter randomized controlled trial is compare standard of care (SOC) to Tenex MicroTip ultrasound therapy plus SOC in patients with Wagner 1-2 diabetic foot ulcers.
- Trial name
- NCT06137222
- Testing
- Tenex TXB MicroTip Ultrasound system plus SOC, Standard of Care for diabetic foot ulcer
- Where
- 2 sites in United States
- Volunteers
- 148 people
- Sponsor
- Tenex Health Inc.
Diabetic Foot Ulcer
A RCT to Compare the Effects of Two Wound Products on Biofilm Disruption in DFUs
This study is a prospective comparative study to determine if an Iodine Gel (Iodosorb◊) is better than standard dressing (Solosite◊ gel) in disruption of biofilm (small microorganism bacteria similar to plaque on teeth) on the…
- Trial name
- NCT02181621
- Testing
- Iodosorb, Solosite gel
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Smith & Nephew, Inc.
Non-healing Wound, Diabetic Foot
AMNIODERM+ Medical Device Clinical Study
This is retrospectively-prospective clinical trial with medical device AMNIODERM+ intended for the non-healing wounds. Retrospective data will contain information about the subject's history and wound treatment by SoC.
- Trial name
- AMNIODERM+ (NCT06442865)
- Testing
- AMNIODERM+
- Where
- Slovakia
- Volunteers
- 20 people
- Sponsor
- BioHealing s.r.o.
Arthritis, Degenerative, Arthritis, Rheumatoid
Excia T Cementless EBRA Study
In this Post Market Clinical Follow-up Study (PMCF Study), the short-term clinical and radiological results of the cementless Excia T® prosthesis in routine clinical use shall be assessed and the migration taking place in the…
- Conditions
- Arthritis, Degenerative, Arthritis, Rheumatoid, Hip Fractures, Femur Head Necrosis
- Trial name
- NCT02799654
- Where
- Germany
- Sponsor
- Aesculap AG
Surgical Wound, Bilateral Total Knee Arthroplasty
Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA
This study will compare the effects of closed incision negative pressure dressing vs. standard of care silver dressing on lower limb swelling after bilateral primary total knee arthroplasty.
- Conditions
- Surgical Wound, Bilateral Total Knee Arthroplasty, Wounds and Injuries, Joint Diseases
- Trial name
- ENABLE (NCT04712019)
- Testing
- Closed Incision Negative Pressure Therapy (ciNPT), Standard Silver-containing Dressing
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- Solventum US LLC
Diabetic Foot, Diabetic Foot Ulcer
Clinical Study Evaluating Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers
The study will evaluate the safety and performance of Symphony™ versus Standard of Care (SOC) in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Foot Ulcer, Chronic Foot Ulcer
- Trial name
- NCT06035536
- Testing
- Symphony™ plus Off-loading, Wound Dressing comprising of calcium alginate Fibracol
- Where
- 11 sites in United States
- Volunteers
- 143 people
- Sponsor
- Aroa Biosurgery Limited
Diabetic Foot Ulcers
Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers
The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, case-matched cohort trial in which diabetic foot ulcers (DFU) will be treated using AutoloGel and case-matched…
- Trial name
- NCT01816633
- Testing
- AutoloGel
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Cytomedix
Wounds, Leg Ulcers
The AutoloGel™ Post-Market Surveillance (TAPS) Program
AutoloGel™ Post-Market Surveillance Program Purpose:Evaluate the incidence of hematologic and immunologic adverse events, including coagulopathies in patients with wounds to which AutoloGel™ was applied.
- Conditions
- Wounds, Leg Ulcers, Pressure Ulcers, Diabetic Foot Ulcers
- Trial name
- TAPS (NCT00762138)
- Testing
- AutoloGel System
- Where
- 2 sites in United States
- Volunteers
- 131 people, healthy volunteers welcome
- Sponsor
- Cytomedix
Diabetic Foot Ulcer
MIRODERM H2H DFU Study
This study will assess the ability of MIRODERM to heal difficult diabetic foot ulcers within 12 weeks of treatment.
- Trial name
- H2H-DFU (NCT03232333)
- Testing
- Biologic wound graft
- Where
- 9 sites in United States
- Volunteers
- 53 people
- Sponsor
- Miromatrix Medical Inc.
Diabetic Foot Ulcer, Diabetic Foot Infection
Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer
This clinical trial evaluates the safety and efficacy of the Nanordica Advanced Antibacterial Wound Dressing (AAWD) in patients suffering from diabetic foot ulcers.
- Trial name
- NM2023 (NCT06667752)
- Testing
- Advanced Antibacterial Wound Dressing, Aquacel Ag+ Extra
- Where
- 11 sites in Estonia, Spain
- Volunteers
- 136 people
- Sponsor
- Nanordica Medical OU