Clinical Trials for Leg Injuries and Disorders

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Leg Injuries and Disorders from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 20
• Active, not recruiting: 6
• Completed: 14
• Other: 10

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT04572256 — MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)

This is a multicenter randomized, placebo-controlled trial to assess whether a 6-month course of oral montelukast after ACL reconstruction reduces systemic markers of inflammation and biochemical and imaging biomarkers of cartilage degradation. This study will specifically target older ACL reconstruction patients with concomitant meniscal injuries as this group is at greatest risk of rapid PTOA…

NCT04791449 — Exercise Enhances Wound Healing in Patients With Diabetic Foot Ulcers

The overarching purpose of this study is to investigate the impact that exercise, as delivered through a medically supervised, outpatient cardiac rehabilitation program, has on the wound healing process in Type 2 diabetics having foot ulcers classified as being Wound, Ischemia, foot Infection (WIfI) stage 2 or lower. The criterion reference measure of diabetic foot ulcer wound healing is be the…

NCT05848622 — Gait Rehabilitation to Treat FastOA

The purpose of this study is to determine the effects of real-time gait biofeedback delivered over a 6-week period on early markers of FastOA and conduct 6-week and 6-month follow-up assessments in anterior cruciate ligament reconstructed patients.

NCT05461326 — Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT

The choice of autograft for ACL reconstruction continues to be debated. To date, there has only be one completed randomized controlled trial with quad tendon to BTB and the tendon included a bone plug. There has been no study to date comparing an all soft tissue quad tendon to patellar tendon in a randomized controlled trial for ACL reconstruction.

NCT07651735 — Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary Hip Prosthesis System

This is a multicenter, prospective, observational, post-market clinical follow-up (PMCF) study designed to evaluate the safety and clinical performance of the Tipmed™ Primary Hip Prosthesis System in adult subjects undergoing primary hip arthroplasty. The study aims to gather real-world clinical evidence on the 24-month post-operative safety profile, potential complications, and functional outc…

NCT06195540 — RIVAroxaban Versus Low-molecular Weight Heparin in Patients With Lower Limb Trauma Requiring Brace or CASTing

Lower limb trauma requiring immobilization is a very frequent condition that is associated with an increased risk of developing venous thromboembolism (VTE). The TRiP(cast) score has been developed to provide individual VTE risk stratification and help in thromboprophylactic anticoagulation decision. The recent CASTING study had confirmed that patients with a TRiP(cast) score <7 have a very lo…

NCT06370273 — Thromboprophylaxis in Lower Limb Immobilisation

The goal of this clinical trial is to find out the clinical and cost effectiveness of Thromboprophylaxis in participants who have been placed in a plaster cast or splint after injury.

The main questions it aims to answer are:

• whether giving tablets to people at high risks of clots after a leg injury is as good as injections (standard care)
• whether giving any medication after a leg injury …

NCT06898814 — The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery

The primary aim of this clinical trial is to investigate the effects of intravenous iron on recovery in mobility compared to the pre-fracture level in patients with a hip fracture

The main questions it aims to answer are:

It is hypothesize that intravenous iron will enhance gains in mobility and hereby recovery of mobility, increase hemoglobin (Hgb), lower fatigue, have a positive effect on s…

NCT06685094 — Translation and Validation of the Limbs, Pain, Autonomy, Depression, Anxiety and Quality of Life Scales in Albanian

The cross-cultural adaptation will be performed according to the internationally recommended methodology, using the following guidelines: translation, back-translation; revision by a committee, questionnaire diffusion and data collection and analyzing.

The psychometric properties will be evaluated by administering the questionnaire to approximately 300 participants. Reliability will be estimat…

NCT07617961 — THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers

Pilot observational clinical evaluation assessing the safety and potential effectiveness of THERAVEX Tissue Care Spray Plus as an adjunctive topical therapy for the management of cutaneous wounds, burns, traumatic lesions, pressure ulcers, diabetic ulcers, and chronic ulcers in 26 patients. The study evaluated wound healing progression, epithelialization, tissue hydration, inflammatory response…

NCT06938685 — Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers

This is a randomized controlled crossover trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating diabetic foot ulcers.

NCT07040683 — Negative Pressure Wound Therapy for Split Thickness Skin Grafting to the Lower Leg After Excision of Skin Tumour: A Multicentre Randomised Study

The goal of this clinical trial is to compare the effect of negative pressure wound therapy (NPWT) versus traditional dressings on the incidence of transplant infection in adult patients undergoing split-thickness skin grafting (STSG) to the lower leg following excision of a skin tumour. The main questions it aims to answer are:

Does NPWT reduce the incidence of transplant infection within thr…

NCT07161830 — Evaluating the Efficacy of OCM™ (Omeza® Complete Matrix) in the Treatment of Diabetic Foot Ulcers

This study aims to compare two treatment approaches for diabetic foot ulcers (DFUs): the standard of care (SOC) alone versus SOC combined with OCM. Researchers will evaluate whether adding OCM increases the likelihood of ulcers healing completely by the end of the trial period.

NCT07239817 — PENG Block + LIA For Endoprosthesis Surgery

The goal of this clinical trial is to learn if a new local anesthesia technique can control pain as well as the standard spinal anesthesia for adults having hip endoprosthesis surgery. The main questions it aims to answer are:

• Is the new local anesthesia technique as effective as standard spinal anesthesia in managing pain during the first two days after surgery?
• Does the new technique all…

NCT06420245 — Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management

The goal of this clinical trial is to learn if use of Orion™, a dual-layer amniotic membrane allograft, in addition to standard wound care treatment can improve patient outcomes for people over the age of 50 with diabetic foot ulcers. The study aims to determine the incidence of complete wound closure at the end of 12 weeks of treatment. Researchers will compare the outcomes between a group of …

NCT07463352 — Preoperative Oral Nutrition And Outcomes In Frail Elderly Patients With Femur Fractures

The goal of this observational study is to learn whether preoperative oral nutrition support improves clinical outcomes in elderly patients with femur fractures who have a high frailty index. The main questions it aims to answer are:

• Does preoperative nutrition support improve hemodynamic stability during and after surgery?
• Does it reduce postoperative complications, mortality, and length …

NCT07632001 — 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.

Diabetic foot ulcers are a common and serious complication of diabetes and may be difficult to heal despite appropriate treatment. Standard of care typically includes regular wound cleaning, debridement (removal …

NCT07668011 — Radial Extracorporeal Shockwave Therapy in Individuals With Iliotibial Band Syndrome

The goal of this Clinical Trial Study is to evaluate the clinical effectiveness of Radial Electrocorporeal Shockwave Therapy (rESWT) combined with exercise in individuals with iliotibial band syndrome (ITBS).The main question it aims to answer is : Does the addition of rESWT to standard ITBS exercise program reduce pain intensity and pain pressure threshold while improving lower extremity funct…

NCT06998134 — Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults

People with cerebral palsy (CP), muscular dystrophy (MD), spina bifida, or spinal cord injury often have muscle weakness, and problems moving their arms and legs. The NIH designed a new brace device, called an exoskeleton, that is worn on the legs and helps people walk. This study is investigating new ways the exoskeleton can be used in multiple settings while performing different walking or mo…

NCT07171489 — Efficacy of a Wearable Noninvasive Neuromodulation Device

The aim of this study is to investigate the potential of transcutaneous neuromodulation (TNM) to treat slow colonic transit and constipation, termed the Neurogenic bowel dysfunction (NBD), in people with SCI. In this project, the study team will investigate the impact of an active treatment intervention vs. a sham control intervention on NBD symptoms in patients with SCI.

The study hypotheses:…

Active, Not Recruiting

NCT03992404 — Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury

The purpose of this study is to determine whether a single treatment with administration of 400 Units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or traumatic brain injury (Main Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact wit…

NCT03935750 — STABILITY 2: Anterior Cruciate Ligament Reconstruction +/- Lateral Tenodesis With Patellar vs Quad Tendon

Anterior cruciate ligament (ACL) rupture is one of the most common musculoskeletal injuries in young individuals, particularly those that are active in sports. Up to 30% of individuals under the age of 20 years suffer a re-injury to the reconstructed ACL. Revision ACLR has been associated with degeneration of the articular cartilage and increased rates of meniscal tears, increasing the risk of …

NCT04944576 — Observational Study to Evaluate Safety and Performance of the Total Ankle Prosthesis, EasyMove®

This study is a post-market clinical follow-up conducted in order to collect long-term data on safety and performance of the EasyMove prosthesis, which is intended to be implanted in case of total ankle replacement, when used in real life conditions according to the instructions for use.

NCT05335252 — Dronabinol After Arthroscopic Surgery

The purpose of the proposed study is to evaluate the efficacy of dronabinol for postoperative pain after arthroscopic surgery of the knee. The investigators hypothesize that dronabinol will relieve pain, reduce opioid consumption and will result in few negative side effects. If this pilot study shows promising results the investigators will expand the trial to include additional arthroscopic su…

NCT06243952 — Brain Controlled Spinal Cord Stimulation In Participants With Spinal Cord Injury For Lower Limb Rehabilitation

The purpose of this clinical study is to evaluate the preliminary safety and effectiveness of using a cortical recording device (ECoG) combined with lumbar targeted epidural electrical stimulation (EES) of the spinal cord to restore voluntary motor functions of lower limbs in participants with chronic spinal cord injury suffering from mobility impairment.

The goal is to establish a direct brid…

NCT06567054 — Clinical Study to Predict the Risk of Bone Fractures With the POROUS Ultrasound Device

Osteoporosis is a widespread medical condition among older people. It causes the bones to weaken and become more likely to break. Osteoporosis and bone fracture risk are currently evaluated by looking at clinical risk factors and measuring bone mineral density (BMD). The lower the BMD is, the higher the risk of osteoporotic fractures in the future. However, most bone fractures occur in people w…

Not Yet Recruiting

NCT07626983 — Botulinum Toxin Type A Versus Local Anesthetic Injection for Chronic Neuroma Pain After Combat-Related Amputation

Patients with combat-related amputations frequently experience persistent neuroma pain that may interfere with rehabilitation, prosthesis use, sleep, mobility, and quality of life. Current treatment options often provide only temporary relief. This study aims to compare two ultrasound-guided injection approaches for chronic neuroma pain after combat-related amputation: botulinum toxin type A an…

NCT07613541 — Translation and Cultural Adaptation of the Erasmus Modified Nottingham Sensory Assessment Scale for the Lower Limb in Acquired Brain Injury Into French

There is a lack of validated and standardized tools in French for assessing somatosensory perception in adults with brain injuries. The only validated tool in French is the Fugl-Meyer Scale for Sensorimotor Recovery after a Stroke, which assesses only light touch sensitivity in two areas of the arm and leg, as well as proprioception for eight joints. The Erasmus Modified Nottingham Sensory Asse…

NCT07621770 — Nutritional Status in Adults With Diabetic Foot Ulcers

This feasibility and pilot study has two aims. The primary aim is to assess the feasibility of collecting clinical, nutritional, and functional data among adults with diabetic foot ulcers (DFUs) who are treated at an outpatient wound clinic. Specifically, the study will evaluate recruitment and inclusion rates, the relevance and clinical utility of selected variables, and assess the completenes…

NCT07163195 — 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 moisture, and transmit this information to a mobile app for nurses to review. Care can then be adjusted in real time.

The purpose of this randomized controlled trial is…

NCT07689227 — Closed-Loop Vagus Nerve Stimulation (CLV) for Recovery of Gait

The purpose of this study is to evaluate the safety, feasibility, and preliminary effectiveness of the ReWire system, which delivers vagus nerve stimulation (VNS) paired with lower limb rehabilitation to improve gait in individuals with mobility impairments resulting from chronic, incomplete spinal cord injury (SCI).

NCT07659184 — IRONCARE: Iron Treatment in Older Patients With Hip Fractures

The aim of this study is to investigate the effects of intravenous (IV) iron therapy compared to alternate-day oral iron treatment and no supplementation in older patients with hip fractures. This study will examine the impact of iron treatment on fatigue, functional decline, fear of falling, cognitive impairment, and quality of life, as well as its effects on iron stores and hemoglobin levels,…

NCT07463365 — LUT017 Gel for Venous Leg Ulcers and Chronic Non-Healing Skin Wounds in Adults

This research study is investigating a new topical medication called LUT017, which is being developed to help heal chronic skin wounds, particularly those known as venous leg ulcers (VLUs). VLUs are open sores that commonly occur on the lower legs due to poor blood flow in the veins. These wounds can be painful, slow to heal, and difficult to treat, especially in older adults and people with co…

Enrolling by Invitation

NCT07653165 — Use of Hydroprep Wound Therapy With Motion Negative Pressure Therapy for Treatment of Chronic Lower Extremity Wounds

Use of a motorized waterjet to debride wounds to improve healing outcomes.

Completed Trials

NCT07637344 — Tactile Guided Lateral Patellar Release

The lateral edge of the patella is identified by the surgeon’s finger and the lateral ligament incision is performed with a blade through the skin.

NCT03504462 — Feasibility of Specific Anesthesia of the Forefoot Preserving the Sensitivity of the Heel for Foot Surgery

Foot surgery is a painful surgery that is usually scheduled in outpatients. A good management of analgesia is the crucial point. Regional anesthesia (RA) is the gold standard, that provides good anesthesia and a long duration of analgesia. The sciatic nerve block (or its branches) is the most adapted analgesic technique.

Limitation of proximal sciatic block is the motor block of the ankle and …

NCT03576989 — Impact of Omega-3 Fatty Acid Oral Therapy on Healing of Chronic Venous Leg Ulcers in Older Adults

The purpose of this study is to test the efficacy of an oral, nutrient intervention containing the bioactive components of fish oil to promote healing of chronic venous leg ulcers (CVLUs) by reducing the chronic inflammation at wound sites that prevents healing progression. If this systemic, nutrient intervention is found to alter the microenvironment of CVLUs, the science of wound healing and …

NCT05662449 — A Cohort Study of Bioabsorbable Screws for Syndesmosis Fixation Fixation in Ankle Fracture

The investigators aim to evaluate the fixation of the ankle syndesmosis in appropriate ankle fractures with bioabsorbable screws.

Ankle fractures are common, and a proportion of them involve both fracture of the bone and also disruption of the syndesmosis, a strong ligamentous complex connecting the distal fibula and tibia. If left without fixation this causes a high incidence of pain and earl…

NCT04618406 — The Effect of Negative Pressure Wound Therapy on Wound Healing in Major Amputations of the Lower Limb

The socioeconomic costs of problematic and delayed wound healing following lower limb amputations are enormous to the society. Lower limb amputations is one of the longest known surgical treatments, but also one of the least investigated in the field of medical science. Negative Pressure Wound Therapy (NPWT) has emerged as a great instrument to aid healing. Studies have shown that it has a posi…

NCT05579743 — Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers

The feasibility phase of the study was conducted to assess the feasibility of a novel, patient-centered, remote wound management system. The investigators will enroll 25 patients with an active diabetic foot ulcer (DFU) who present to the multidisciplinary diabetic foot clinic in Baltimore, Maryland.

The RCT is being done to compare two different methods of wound monitoring for chronic wounds:…

NCT07555782 — Shear-Wave Elastography of Regenerated Hamstring Tendons After ACL Reconstruction (SWE-ACL)

Anterior cruciate ligament (ACL) reconstruction using autologous hamstring tendon grafts is a commonly performed procedure. Although the semitendinosus and gracilis tendons demonstrate regeneration at the donor site, the structural and biomechanical properties of the regenerated tissue may differ from native tendon, potentially affecting muscle function.

This study aims to quantitatively asses…

NCT07639762 — Comparison of the Efficacy of Ultrasound-guided Supra-inguinal Fascia Iliaca and Lumbar Erector Spina Plan Block in Hip Fractures

The aim of our study was to evaluate the efficacy and patient satisfaction level of SI-FIB and lumbar ESPB for positioning and postoperative analgesia during spinal anesthesia in patients undergoing hip fracture surgery.

NCT07689916 — Machine Learning-Based Risk Identification and Precision Exercise for Common Running Injuries

This study aims to identify biomechanical risk factors associated with common running-related injuries in recreational runners using machine learning analysis. It also aims to evaluate whether a precision exercise intervention based on these risk factors can improve injury-related biomechanical and kinematic outcomes.

The main questions it aims to answer are:

Which biomechanical features iden…

NCT07338773 — Intraosseous Versus Intravenous Vancomycin in Below-Knee Amputation for Ischemic Diabetic Foot

This randomized clinical trial compared two routes of vancomycin administration in patients undergoing below-knee amputation for ischemic diabetic foot infection. Patients with diabetic foot infection and impaired lower-extremity circulation may have reduced delivery of intravenously administered antibiotics to the amputation stump. Intraosseous administration may increase local antibiotic expo…

NCT07124247 — Implementation of the MOX Activity Monitor in Hospitalized Geriatric Rehabilitation

Staying active is essential for healthy aging, but hospitalized older adults in rehabilitation often move very little. This study explores how much physical activity these patients actually get and how it relates to their recovery. Using the MOX activity monitor-a device that accurately tracks walking, standing, and sedentary time-the study aims to better understand daily activity patterns duri…

NCT07690566 — Ultrasonic Enhancement Delivery of Phosphodiesterase Inhibitors Nanoparticles for Diabetic Management of the Foot

The enhancement of cGMP levels at the wound site has shown beneficial effects in wound healing. Thus, topical or systemic application of phosphodiesterase 5 (PDE5) inhibitors, for example, sildenafil (Viagra), which is well-known for its use in the treatment of erectile dysfunction, enhanced contraction, re-epithelialization, and tensile strength of rat wounds and reduced pressure ulcer size in…

NCT07255937 — PMCF Study of Debridement Pad

The design of the study is a clinical trial of Debridement Pad in subjects with superficial, chronic and acute wounds consisting of Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by secondary intention, traumatic or surgical wounds and burns and scalds. The performance data from this study will support clinically meaningful rates of successful imp…

NCT07128901 — Lower-Limb Exoskeleton Technology for Non-Ambulatory Individuals With Spinal Cord Injury

The purpose of this study is to compare two types of wearable lower-extremity exoskeletons -a self-balancing device lower-extremity exoskeleton and a user-balancing device lower-extremity exoskeleton-to better understand their effects on the physiological responses to walking and the user experience in people with spinal cord injury.

Other (Terminated)

NCT06572839 — Amnio-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone

This randomized controlled study evaluates the adjuvant use of Amnio-Maxx in patients with diabetic foot ulcers

NCT06455475 — Derm-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone

This randomized controlled study evaluates the adjuvant use of Derm-Maxx in patients with diabetic foot ulcers