Clinical trials: Lower Limb
Diabetic Foot Ulcer
Topical Erythropoietin Hydrogel Formulation for Diabetic Foot Ulcers
Remedor has developed a patented technology (RMD-G1), which comprises erythropoietin (EPO) as the active pharmaceutical ingredient (API) in a carbopol-based hydrogel with an FN matrix.
- Trial name
- Remede d'Or (NCT02361931)
- Testing
- A hydrogel containing erythropoietin, Hydrogel (as a part of SOC)
- Where
- 5 sites in Israel
- Volunteers
- 20 people
- Sponsor
- Remedor Biomed Ltd
Diabetic Foot Ulcer
The ASCEND Study: A Study to Investigate the Safety and Clinical Effect of Nexagon to Treat Slow Healing Diabetic Foot Ulcers
Diabetic foot ulcers are sores on the feet that occur in 15% of diabetic patients some time during their lifetime. Once an ulcer develops, the risk of lower-extremity amputation is increased 8-fold in people with diabetes.
- Trial name
- NCT00820703
- Testing
- Nexagon®, Nexagon® vehicle
- Where
- New Zealand
- Volunteers
- 24 people
- Sponsor
- OcuNexus Therapeutics, Inc.
Diabetic Foot
BE Study of Metformin GSK 500mg
A randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study under fasting condition. It is a pivotal study.
- Trial name
- BA/BE 173/11 (NCT01710527)
- Testing
- Metformin 500mg, Glucophage 500mg
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Venous Leg Ulcer, Leg Ulcers Venous
Efficacy Study for Geko Device in VLU Patients
Eight weeks, comprised of four weeks Run-in Phase of Standard Care (SC) treatment followed by four weeks of treatment allocated by randomisation (Treatment Phase).
- Conditions
- Venous Leg Ulcer, Leg Ulcers Venous, Leg Ulcer, Wound Leg
- Trial name
- NCT03396731
- Testing
- geko™ medical device
- Where
- 23 sites in United Kingdom
- Volunteers
- 171 people
- Sponsor
- Firstkind Ltd
Diabetic Peripheral Neuropathy
Effect of Pulsing Electrical Fields on Lower Extremity Diabetic Neuropathy: A Pilot, Open-Label Study
To determine if pulsed electric field therapy reduces lower leg and foot pain associated with diabetic neuropathy and lessens the need for medication.
- Trial name
- DPN (NCT00614341)
- Testing
- MedRelief SE 55
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- MedRelief
Diabetic Foot Ulcer, Diabetes Mellitus
CSTC1 for Diabetic Foot Ulcers Phase II Study
The objective of this study is to evaluate the efficacy and safety of CSTC1 in patient with diabetic foot ulcers.
- Conditions
- Diabetic Foot Ulcer, Diabetes Mellitus, Wounds
- Trial name
- NCT01813305
- Testing
- CSTC1, CSTC1 Matched vehicle
- Where
- Taiwan
- Volunteers
- 124 people
- Sponsor
- Charsire Biotechnology Corp.
Diabetic Foot, Diabetic Peripheral Neuropathy
Monitoring Physiologic Parameters in Individuals With Diabetic Peripheral Neuropathy
The primary aim of this study is to use the Orpyx® SI Sensory Insole System (Orpyx Medical Technologies Inc., Calgary AB, Canada) ("Orpyx" or "the Company") as an adjunct to diabetic peripheral neuropathy standard of care (SOC)…
- Trial name
- NCT05613556
- Testing
- Orpyx SI® Sensory Insole System
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Orpyx Medical Technologies Inc.
Spinal; Nerve Root, Pain, Pelvic Pain
Quality of Life and Pain Changes Due to DRG Stimulation for Chronic Pain
ACTIVE study- a prospective observational clinical study examining the changes in quality of life and pain following dorsal root ganglion stimulation for the treatment of chronic intractable pelvic and lower limb pain.
- Conditions
- Spinal; Nerve Root, Pain, Pelvic Pain, Regional Pain Syndrome, Chronic Pain Syndrome
- Trial name
- ACTIVE (NCT03417973)
- Testing
- dorsal root ganglion neuromodulation
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- KM Clinical Research Group
Diabetic Foot Ulcer, Dehiscence of Amputation Stump
Kerecis Omega3 Wound Plus SOC vs. SOC Alone in Treating Severe Diabetic Foot Ulcers and Forefoot Amputations
This is a prospective, multi-national, multi-centre, randomized, non-blinded (photo evaluation is blinded), controlled clinical investigation in patients suffering from diabetic wounds reaching to tendon, bone, or joint.
- Conditions
- Diabetic Foot Ulcer, Dehiscence of Amputation Stump, Amputation
- Trial name
- Odinn (NCT04257370)
- Testing
- Kerecis™ Omega3 Wound, Standard of care
- Where
- France
- Volunteers
- 260 people
- Sponsor
- Kerecis Ltd.
Stroke, Wound Heal
Study of gekoTM Interaction With Cardiac Pacemakers
The gekoTM device is a small disposable battery powered device that attaches to the lower leg near the knee and stimulates the common peroneal nerve, causing muscle contraction of the lower leg.
- Conditions
- Stroke, Wound Heal, Edema Leg, Cardiac Pacemaker Electrical Interference
- Trial name
- NCT04391257
- Testing
- geko™
- Where
- 2 sites in United Kingdom
- Volunteers
- 28 people
- Sponsor
- Firstkind Ltd
Diabetic Foot Ulcer
Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers
This is a phase II single-blinded study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to standard therapy.
- Trial name
- NCT02619877
- Testing
- ALLO-ASC-DFU, Standard therapy
- Where
- 4 sites in South Korea
- Volunteers
- 59 people
- Sponsor
- Anterogen Co., Ltd.
Knee Injuries and Disorders
AIR (Artificial Implant to Restore the Medial Meniscus Function)2 Clinical Investigation
The AIR2 Study is a multi-center, prospective, interventional clinical trial with the objective to evaluate the safety and performance of the Trammpolin® medial meniscus prosthesis.
- Trial name
- AIR2 (NCT05297175)
- Testing
- Trammpolin medial meniscus prosthesis
- Where
- 3 sites in Netherlands
- Volunteers
- 10 people
- Sponsor
- ATRO Medical B.V.
Chronic Pain
A Study to Evaluate the Effect of Precision Spectra™ Programming Features and Lead Options on Patient Outcomes
The study is a prospective, on-label, multi-center, blinded, randomized controlled trial with a cross-over design to evaluate the effect of Precision Spectra™ SCS System's programming features and lead options.
- Trial name
- COVERAGE (NCT02384096)
- Testing
- Conventional single source programming, Precision Spectra SCS System advanced programming
- Where
- 4 sites in United States
- Volunteers
- 17 people
- Sponsor
- Boston Scientific Corporation
Anterior Cruciate Ligament Tear
Bone Marrow Aspirate Concentrate for Anterior Cruciate Ligament Tear Treatment.
A single armed multicenter study enrolling 20 patients using autologous bone marrow aspirate concentrate (which is done under local or general anesthesia to aspirate around 1-2 cc/kg body weight then concentration which is done…
- Trial name
- NCT06353503
- Testing
- autologous bone marrow aspirate concentrate
- Where
- Iraq
- Volunteers
- 20 people
- Sponsor
- abdulmajeed hammadi
Abdominal Wound Dehiscence, Necrotizing Soft Tissue Infection
Myriad™ Augmented Soft Tissue Reconstruction Registry
This is an observational study designed to evaluate the safety and clinical outcomes of Myriad™ in soft tissue reconstruction procedures.
- Conditions
- Abdominal Wound Dehiscence, Necrotizing Soft Tissue Infection, Lower Extremity Wound, Pilonidal Sinus
- Trial name
- MASTRR (NCT05243966)
- Testing
- Myriad Matrix™ and Myriad Morcells™
- Where
- 15 sites in United States
- Volunteers
- 800 people
- Sponsor
- Aroa Biosurgery Limited
Pareses, Lower Extremity
Clinical Trial Comparing C-Brace to Knee Ankle Foot Orthosis (KAFO)/Stance Control Orthosis (SCO)
Prospective, international, multi-center, open-labeled, randomized, controlled cross-over trial to evaluate effectiveness and benefits in patients with lower limb impairment in activities of daily living comparing the C-Brace…
- Trial name
- NCT03906656
- Testing
- C-Brace, KAFO/SCO
- Where
- 13 sites in United States, Austria and 2 more
- Volunteers
- 149 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Peripheral Arterial Disease
Comparison of Lower Limb Endovascular Interventions With and Without the EndoNaut Workstation
To demonstrate that the use of EndoNaut for endovascular procedures on the femoropopliteal axis has a clinical impact for the patient (decrease in irradiation and the volume of contrast product) as well as for nursing staff…
- Trial name
- COMPAR-MI (NCT04709991)
- Testing
- Endovascular procedure
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Therenva
Arterial Thrombosis
JETi Lower Extremity Arterial Thrombosis
The JETi Registry is a prospective, single-arm, multi-center study to collect real-world data on the safety, performance, and clinical benefits of the JETi™ Hydrodynamic Thrombectomy System (JETi System) for the treatment of…
- Trial name
- JETi (NCT04370691)
- Testing
- JETi lower extremity arterial thrombosis
- Where
- 30 sites in United States, Australia and 2 more
- Volunteers
- 129 people
- Sponsor
- Abbott Medical Devices
Ankle Sprain
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain
The purpose of this study is to evaluate the efficacy of Diclofenac Sodium Topical (DSG) 1% compared with placebo applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard…
- Trial name
- NCT01255423
- Testing
- Diclofenac sodium topical gel 1%
- Where
- 9 sites in United States
- Volunteers
- 206 people
- Sponsor
- Novartis
Femoral Fracture
Post Market Clinical Evaluation of Gamma 4
This is a prospective, multi-center, non-randomized, post-market clinical investigation of the Gamma 4 System. Neither subjects nor investigators are blinded to treatment.
- Trial name
- PEGASUS (NCT05523635)
- Testing
- Gamma4 Nailing System
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- Stryker Trauma and Extremities