Clinical Trials for Foot 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 Foot Injuries and Disorders from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 18
• Active, not recruiting: 0
• Completed: 19
• Other: 13

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

Recruiting Trials

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…

NCT05555459 — Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation

The study in question is a post market clinical follow up (PMCF) study to evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations of the foot and ankle. The study recruits 125 adult patients who meet the acceptance criteria. The follow-up time for each study patient is 4 years. The study is a sin…

NCT05644522 — Nomad P-KAFO Study

The goal of this clinical trial is to evaluate the impact of using the Nomad powered KAFO in people who have had a musculoskeletal or neurological injury that has affected their ability to walk. The main questions it aims to answer are to quantify the effectiveness of the Nomad in improving mobility, balance, frequency of falls, and quality of life in individuals with lower-extremity impairment…

NCT05172089 — Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence

This work is based on DFU patients, seeks to conduct a fully powered clinical study testing i) If DFU with a history of biofilm infection closes with deficient barrier function. ii) whether such functionally deficient wound closure, manifested as high TEWL, is associated with greater wound recurrence. The primary parent study will also address molecular mechanisms implicated in biofilm-induced …

NCT06515093 — Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC

The purpose of this study is to compare Pellograft to standard of care modalities in treating diabetic foot ulcers in human subjects, and to compare Sanograft to standard of care in treating venous leg ulcers. The study will demonstrate wound healing outcomes with comparators including time to wound epithelialization, decrease in wound size, and total number of study product applications toward…

NCT06721754 — Diabetes Related Foot Ulcers With Negative Pressure Wound Therapy

The goal of this study is to learn if the clinical effects of Negative Pressure Wound Therapy (NPWT) is better, worse or the same as standard wound care for patients with diabetic foot ulcers (DFUs).

The main questions it aims to answer are:

• Will there be a difference in the number of major amputations between the groups during the first year?
• Will one of the treatments require more surge…

NCT06780202 — Assessment of Medrol Dosepak to Reduce Opioid Consumption in Foot and Ankle Surgical Patients

This clinical trial aims to determine the effects of a 6-day low-dose methylprednisolone course on pain, nausea, and total opioid consumption in patients undergoing foot and ankle surgeries.

The secondary objective of the study is to determine and monitor the effects of the course on complications following surgery and patient-reported outcomes

NCT07086443 — Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy

The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.

NCT07482137 — Therapeutic Effect of Electroacupuncture at Zusanli (ST-36) on Diabetic Foot Wounds

The goal of this clinical trial is to learn if electroacupuncture at the Zusanli (ST-36) can assist in the treatment of diabetic foot ulcers. The main question it aims to answer is: Can electroacupuncture at the Zusanli (ST-36) promote wound healing in patients with diabetic foot ulcers?

Researchers will compare outcomes between participants receiving electroacupuncture plus standard treatment…

NCT07538141 — The Hyalex MTP Study

The HYALEX SLALOM MTP Hemiarthroplasty System consists of a synthetic implant designed to replace the distal metatarsal surface of the great toe for treatment of arthritis . The system is composed of the HYALEX MTP Implant and instrumentation. The implant consists of the HYALEX Cartilage material bonded to a titanium backing.

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.

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.

NCT07231471 — Platelet Rich Plasma for Musculoskeletal Conditions

The primary purpose of this study is to follow patients with various musculoskeletal (MSK) conditions over a one-year follow-up period after receiving a platelet rich plasma (PRP) injection, assessing changes in their pain levels, functional abilities, and overall patient satisfaction.

This will develop a robust registry of patients treated with PRP for a range of MSK conditions. These conditi…

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 …

NCT07558564 — Evaluation of Platelet-Rich Plasma (PRP) Treatment in Tendinopathies

This multicenter, prospective, observational study, based on real-world evidence (RWE), aims to evaluate the efficacy and safety of Platelet-Rich Plasma (PRP) treatment across four types of tendinopathies: patellar, Achilles, epicondylar, and plantar fasciosis. Data collection and analysis will be conducted using the BioSmartData® platform, including hematology analyzers for PRP characterizatio…

NCT07541196 — PAW-Hydrogel for Chronic Wound Healing

The goal of this randomized controlled trial is to evaluate the efficacy and safety of a novel hydrogel made of Carbopol® 940 functionalized with Plasma-Activated Water (PAW) in patients with chronic wounds (diabetic foot ulcers, pressure injuries, dehiscent wounds, arterial and venous ulcers). The main questions it aims to answer are:

• Does PAW-hydrogel accelerate wound closure (reduction in…

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 …

Not Yet Recruiting

NCT07465640 — Evaluating the Efficacy of Pulsating Electromagnetic Field Therapy by CRAD ULCER X-01 for Diabetic Foot Ulcers

Background: Diabetic foot ulcer (DFU) is a frequent complication of chronic, uncontrolled diabetes mellitus (DM). Treatment with antibiotics, daily dressing, wound debridement, and wound off-loading is often prescribed. However, many DFU patients still progress into severe outcomes, including non-healing of wounds, infections, necrosis, and osteomyelitis. Prior research has shown that the appli…

NCT07452354 — AI-Based Diabetic Foot Recurrence Cohort

Diabetic foot ulcer (DFU) is a major adverse outcome of diabetes, which itself is one of the most significant chronic diseases. The recurrence of DFU involves multiple risk factors, including altered foot loading patterns, patient compliance, family care capacity, blood glucose monitoring, degree of ischemia, and systemic disease control. Early identification of recurrence signs and timely foll…

NCT07375160 — Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing

The retrospective trial is observational, intended to stand alone, complement and integrate data collected in ongoing clinical studies to aid in establishing payor coverage in the United States (U.S.) for Cellution Biologics allograft products with real-world evidence to support the clinical adoption in patients to manage chronic or surgical wounds.

NCT07290673 — Evaluating the Efficacy of FoundationDRS Solo in Addition to Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers

The goal of this clinical trial is to learn if using FoundationDRS Solo improves healing of chronic, non-healing foot ulcers in diabetic patients.

The main question that this study aims to answer is:

Does FoundationDRS Solo, when used in conjunction with standard of care wound management techniques, result in a higher percentage of target ulcers achieving complete closure (i.e. healing) as co…

NCT07099482 — “Ultrasound-Enhanced Propolis Therapy for Healing Diabetic Foot Wounds”

This study aims to evaluate whether using ultrasound (phonophoresis) can help deliver propolis-a natural compound made by bees-more effectively into the skin to speed up wound healing in people with diabetic foot ulcers. Diabetic foot ulcers are a common and serious complication of diabetes and often take a long time to heal. Propolis has natural anti-inflammatory and antimicrobial properties t…

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…

NCT07438951 — A Study on the Efficacy and Safety of a Nitric Oxide Generating Dressing in the Treatment of Diabetes Related Foot Ulcers.

Real world evidence study on the performance and safety of a nitric oxide generating dressing on the treatment of diabetic foot ulcers

NCT07395674 — Subcutaneous Dexpanthenol Administration and Wound Epithelialization

Chronic wounds are wounds that do not heal properly over time and can significantly reduce quality of life. Common types include diabetic foot ulcers, venous leg ulcers, and arterial ulcers. Improving wound healing and speeding up skin regeneration (epithelialization) are important goals in the care of these patients.

Dexpanthenol is a vitamin B5 derivative that supports skin repair and tissue…

Enrolling by Invitation

NCT06328010 — 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.

NCT06439667 — Tele-Exercise Platform for Plantar Wound Healing

The purpose of the study is design and use a telemedicine platform which integrates video-chat, pre-programmed interactive game-based foot, and ankle exercise modules, and real-time quantitative performance metrics displayed to the clinician to improve patient’s perfusion to the lower extremity, improve diabetic wound healing and prevent muscle loss in the lower extremity.This is a cross sectio…

Completed Trials

NCT01961557 — Evaluating a New Knee-Ankle-Foot Brace to Improve Gait in Children With Movement Disorders

Background:

- Cerebral palsy (CP) is the most common motor disorder in children. CP often causes crouch gait, an abnormal way of walking. Knee crouch has many causes, so no single device or approach works best for everybody. This study s adjustable brace provides many types of walking assistance. Researchers will evaluate brace options to find the best solution for each participant, and wheth…

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 …

NCT07493343 — EUSOL vs. PDGF Dressing for Diabetic Foot Ulcers

Diabetic foot ulcers are a major cause of morbidity and amputation. This randomized controlled trial will compare the efficacy of a traditional antiseptic dressing (EUSOL) with a modern biologic dressing containing Platelet-Derived Growth Factor (PDGF) in promoting wound contraction. The study aims to determine if PDGF dressing leads to better healing outcomes in patients with Grade II Wagner d…

NCT05193929 — A Clinical Investigation Evaluating Wound Closure With OptiPulse™ Versus SOC in the Treatment of Non-Healing DFU’s

The purpose of this clinical investigation is to assess the safety and performance of Compedica’s OptiPulse™ and to collect subject outcome data on the treatment of diabetic foot ulcers (DFU’s) versus the standard of care (SOC). OptiPulse™ is designed to enhance blood circulation in the venules and arterioles. Fibracol Plus (or equivalent) is a collagen alginate dressing that is used as the pri…

NCT05170984 — 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.

This study is a prospective and standardized recording of patients’ data followed in real-life conditions to appreciate the benefits of a therapeutic strategy including CACIPLIQ20® use. It also aims at collecting d…

NCT05494645 — Exparel Use in Peripheral Nerve Blocks and Local Infiltration for Foot and Ankle Surgery

Liposomal Bupivacaine (Exparel) has been recently studied as the active agent utilized in various nerve block. Due to its liposomal form allowing for extended delivery, Exparel has been used in various peri-operative nerve blocks among multiple orthopaedic specialties in hopes of achieving improved pain control and decreased opioid use. This study compares the efficacy and effect on opioid use …

NCT05189470 — Inforatio Technique to Promote Wound Healing of Diabetic Foot Ulcers

This randomized clinical trial will examine the effect of inforatio technique on healing of diabetic foot ulcers (DFUs).

Inforatio technique is a novel procedure developed by the research group. The definition of inforatio technique is application of small cuts in wound beds with punch biopsy tools without involving surrounding epithelia. The aim is to initiate an acute inflammatory response t…

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:…

NCT05977309 — Effect of Topical Ozone on The Healing Diabetic Foot Ulcer

Despite conflicting and contradictory evidence regarding its efficacy, some wound care centres have advocated and adopted ozone for treating DFU. However, there are gaps in the application of topical ozone therapy. Reported no significant impact on the healing process of DFU, and not all said that topical ozone can enhance the healing process. This study aimed to compare the efficacy of topical…

NCT06054659 — CGM and DFU Healing Post-discharge

The purpose of this study is to look at the benefits of using a Continuous Glucose Monitoring (CGM) system compared with standard-of-care testing for patients with type 2 diabetes and diabetic foot ulcers (DFU) and how this will improve wound healing.

The CGM system allows medical staff and patients with diabetes to monitor and make treatment decisions to improve glucose control, without the n…

NCT07549737 — Effectiveness of Silicone Superabsorbent Polymer Dressings for Chronic Wound Management

The purpose of this single arm clinical study is to find out how well two Silicone superabsorbent polymer dressings, RespoSorb Silicone (also known as Zetuvit Plus Silicone) and RespoSorb Silicone Border (also known as Zetuvit Plus Silicone Border), work in treating long lasting wounds on the lower legs or feet. The main goal of the study is to see whether these dressings help reduce wound size…

NCT06526884 — Quasi-Randomized Evaluation of the UCLA Next Day Clinic (NDC)

The Next Day Clinic (NDC) is a quality improvement initiative that will be launched and operated by UCLA Health starting July 22, 2024. Its goals are to improve patient care and safety and to maximize cost effectiveness. The way it does this is by identifying patients in the ED who would normally be admitted for low-acuity conditions, and diverting them to a high-acuity clinic the following day…

NCT06416462 — Action of Photodynamic Therapy on Wound Quality and Tissue Repair in the Diabetic Foot

Diabetic foot ulcer affects 10.5% of the Brazilian/world population, compromising the quality of life of these patients and burdening the public health system. Studies show that antimicrobial photodynamic therapy (aPDT) accelerates its repair, however, there is not enough evidence for decision-making in clinical practice, which prevents this treatment from being used on a large scale. Controlle…

NCT06569238 — Diabetic Foot Ulcer (DFU) Rapid Pathogen Identification

The purpose of this study is to evaluate the role of rapid diagnosis of pathogens in treatment of infection and wound healing in diabetic foot ulcers. This research is studying the use of a new device of people to learn if metagenomic next generation sequencing (mNGS) techniques technology is a feasible tool that can be used to direct targeted antibiotic therapy in infected diabetic foot ulcers…

NCT07420868 — Comparison of Platelet-Rich Plasma Dressing Versus Normal Saline Dressing for Chronic Non-Healing Ulcers

This randomized controlled trial will compare platelet rich plasma dressing with normal saline dressing for the treatment of chronic non healing cutaneous ulcers, including diabetic foot ulcers, venous leg ulcers, pressure ulcers, and other suitable chronic ulcers of at least six weeks duration. A total of 100 adults will be recruited from the Department of Dermatology, Multan Medical and Denta…

NCT07066371 — The Effect of Emotional Freedom Technique on Patients Receiving Preventive Foot Care

It is planned to examine the effect of the emotional liberation technique on the anxiety level in patients who receive preventive foot wound care and treatment in the postoperative period.

H0: The emotional liberation technique has no effect on the anxiety level in patients who receive preventive foot wound care and treatment in the postoperative period.

H1: The emotional liberation technique…

NCT07442110 — This Observational Study Evaluates the Clinical Outcomes of Patients With Diabetes Who Utilize a Specialized Dietary Supplements for Foot Ulcer Healing. The Study Documents the Rate of Complete Wound Closure and the Prevention of Lower Extremity Amputations in a Real-world, At-home Setting.

This observational study evaluates the clinical outcomes of patients with diabetes who utilize a specialized dietary supplements for foot ulcer healing. The study documents the rate of complete wound closure and the prevention of lower extremity amputations in a real-world, at-home setting.

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…

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…

Other (Terminated)

NCT04927702 — Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)

In participants with diabetic foot ulcers (DFUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with standard of care.

In participants with venous leg ulcers (VLUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with living cellular skin substitute (Apligraf®)

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