Clinical trials: Foot Surgery
Osteoarthritis, Hallux Rigidus
Artelon Metatarsophalangeal (MTP) Spacer
The aim of this prospective, case series is to evaluate the surgical treatment of painful and disabling osteoarthrosis in the MTP-I joint by insertion of an Artelon MTP Spacer.
- Trial name
- NCT01028469
- Testing
- Artelon MTP Spacer
- Where
- Sweden
- Volunteers
- 15 people
- Sponsor
- Artimplant AB
Surgical Incision, Ulcer Foot
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot…
- Conditions
- Surgical Incision, Ulcer Foot, Ulcer Venous, Ulcer, Leg
- Trial name
- PICO14 (NCT05234632)
- Testing
- PICO 14 single-use Negative Pressure Wound Therapy System
- Where
- 6 sites in Germany, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Smith & Nephew, Inc.
Surgery, Edema
Foot and Ankle Post-operative Oedema Management Using Geko™
The multicentre randomised geko™ Foot and Ankle Trial will prospectively and systematically collect clinical data on patients randomised, on a 1:1 basis, to either standard care or standard care plus geko™ therapy to assess…
- Trial name
- NCT04927234
- Testing
- geko™ therapy
- Where
- 5 sites in United States, Spain and 1 more
- Volunteers
- 123 people
- Sponsor
- Firstkind Ltd
Postoperative Pain
Phase 2 Bunionectomy HTX-011 Administration Study
This is a Phase 2, open-label, multi-cohort study to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of a single, individualized dose of HTX-011 administered into the surgical site as a monotherapy or with…
- Trial name
- NCT03718039
- Testing
- HTX-011, Luer Lock applicator, Vial access device
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Heron Therapeutics
Diabetic Foot Ulcer, Surgical Wound
The Effect of Natrox® Oxygen Wound Therapy on the Healing Rate of Chronic Diabetic Foot Ulcers
A Multicentre Randomized Controlled Trial to Investigate the Effect of Natrox Topical Oxygen Wound Therapy on the Healing rates of Diabetic Foot Ulcers.
- Trial name
- NCT03905863
- Testing
- Natrox® Oxygen Wound Therapy
- Where
- 20 sites in United States, Puerto Rico
- Volunteers
- 145 people
- Sponsor
- Inotec AMD Limited
Bunion
A Study to Evaluate Analgesic Efficacy and Safety of PRF-110 for Post-surgical Pain
PRF-110 is a viscous, yellowish clear oily solution of ropivacaine intended for administration into surgical sites to provide post-operative analgesia.
- Trial name
- NCT05773846
- Testing
- Ropivacaine
- Where
- 7 sites in United States
- Volunteers
- 428 people
- Sponsor
- PainReform LTD
Pain
Efficacy and Safety Study of 4975 to Manage Pain of Bunionectomy
The primary purpose of this study is to compare the analgesic efficacy of a single intraoperative administration of 4975 vs. Placebo in the management of acute postoperative pain in patients undergoing bunionectomy.
- Trial name
- NCT00656578
- Testing
- 4975
- Where
- 6 sites in United States
- Volunteers
- 300 people
- Sponsor
- Anesiva, Inc.
Leg Ulcer, Diabetic Foot Ulcer
Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice
This is a post - market study with a wound dressing, a CE-marked medical device available on the european market. The device will be used in routine clinical practice, i.e.
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer, Surgical Wound
- Trial name
- GELFI (NCT05148390)
- Testing
- Cutimed® Gelling Fiber
- Where
- Germany
- Volunteers
- 36 people
- Sponsor
- BSN Medical GmbH
Pain, Post-operative
Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy Surgery
The primary objective of this study is to evaluate the analgesic efficacy, on Post-Operative Day (POD) 1, of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48 hours (SPID48) in subjects…
- Trial name
- NCT02284243
- Testing
- Intranasal Dexmedetomidine
- Where
- 3 sites in United States
- Volunteers
- 168 people
- Sponsor
- Baudax Bio
Symptomatic Neuroma, Morton's Neuroma
Study of AxoGuard® Nerve Cap and Neurectomy for Treatment of Symptomatic Neuroma & Prevention of Recurrent Neuroma Pain
Comparing safety, pain, user experience, healthcare economic costs, work productivity, impairment and quality of life outcomes between Axoguard® Nerve Cap and neurectomy in the treatment of symptomatic neuromas in the foot or…
- Conditions
- Symptomatic Neuroma, Morton's Neuroma, Chronic Nerve Pain
- Trial name
- REPOSE (NCT03940963)
- Testing
- AxoGuard® Nerve Cap, Standard Neurectomy
- Where
- 11 sites in United States
- Volunteers
- 86 people
- Sponsor
- Axogen Corporation
Foot Diseases
Ambispective, Multicentre, Open-label Study Evaluating the Clinical Outcomes of Foot Surgery Using SERF Medical Devices
This clinical investigation was led as a post-marketing clinical follow-up study conducted as part of standard care with an additional, non-invasive, non-invasive procedure (Case 4.1) ambispective, multicentre, open-label…
- Trial name
- NCT05672069
- Testing
- Osteosynthesis
- Where
- France
- Volunteers
- 124 people
- Sponsor
- Societe dEtude, de Recherche et de Fabrication
Hallux Valgus
Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery
Study designed to evaluate the efficacy and safety of Intranasal (IN) Morphine Nasal Spray (MNS075) 3.75 mg, 7.5 mg, 15 mg, and 30 mg, intravenous (IV) morphine 7.5 mg, or IN placebo in patients with moderate to severe…
- Trial name
- NCT00388011
- Testing
- Intranasal Morphine (MNS075) 3.75 mg, Intravenous Morphine 7.5 mg, Intranasal morphine (MNS075) 7.5 mg
- Volunteers
- 187 people
- Sponsor
- Javelin Pharmaceuticals
Pain, Post-operative
Placebo-Controlled Evaluation of N1539 Following Bunionectomy Surgery
The primary objective of this study is to evaluate the safety of N1539 in subjects with acute moderate to severe pain following unilateral bunionectomy.
- Trial name
- NCT02540265
- Testing
- N1539
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Baudax Bio
Foot and Ankle Disorders, Ankle Fusion, Osteotomy
Burst Biologics Foot and Ankle Registry
This prospective registry was designed as an observational study to ascertain how commercially available Burst Products are being used by foot and ankle surgeons performing procedures which involve bone grafting, as well as…
- Trial name
- NCT03077256
- Testing
- BioBurst Fluid, Burst Allograft
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Burst Biologics
Foot Injuries and Disorders
Nutritional Supplements and Foot Surgery
This is a prospective randomized trial wherein participants will be assigned to NutraHeal™, NutraHeal Plus™, or standard of care for 1 week prior to foot surgery and 3 weeks after surgery.
- Trial name
- NCT05522179
- Testing
- NutraHeal, NutraHeal Plus
- Where
- 3 sites in United States
- Volunteers
- 46 people
- Sponsor
- NutraHeal
Chronic Wounds, Venous Leg Ulcers (VLUs)
Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds
Chronic wounds constitute a significant global health burden, affecting millions of individuals and contributing to increased morbidity, diminished quality of life, and rising healthcare costs.
- Conditions
- Chronic Wounds, Venous Leg Ulcers (VLUs), Diabetic Foot Ulcers (DFUs), Arterial Ulcers
- Trial name
- NCT07223892
- Testing
- Amniotic Tissue Allograft
- Volunteers
- 600 people
- Sponsor
- Bardia Anvar
Medial Malleolus Fracture, Lisfranc Injury
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…
- Conditions
- Medial Malleolus Fracture, Lisfranc Injury, Lisfranc Fracture, Talus Fracture
- Trial name
- NCT05555459
- Testing
- Operation
- Where
- Finland
- Volunteers
- 125 people
- Sponsor
- Inion Oy
Degenerative and Traumatic Pathology of the Knee, Degenerative and Traumatic Pathology of the Shoulder and Elbow
Web Based Orthopaedic Sports Medicine Registry
The purpose of this study is to establish an international, web based clinical registry to collect baseline characteristics of patients undergoing orthopaedic, sports medicine, arthroscopy, and related surgery, and the subsequent…
- Conditions
- Degenerative and Traumatic Pathology of the Knee, Degenerative and Traumatic Pathology of the Shoulder and Elbow, Degenerative and Traumatic Pathology of the Foot and Ankle, Degenerative and Traumatic Pathology of the Hand and Wrist
- Trial name
- NCT01191151
- Where
- 258 sites in United States, Canada and 3 more
- Volunteers
- 12,500 people
- Sponsor
- Arthrex, Inc.
Foot Diseases
Study to Evaluate Safety, of NextraTM in Surgery to Fuse the Proximal-interphalangeal- Joints
Hammertoe deformity is the most common deformity of the lesser toes. It primarily comprises flexion deformity of the proximal interphalangeal (PIP) joint of the toe, with hyperextension of the metatarsophalangeal (MTP).
- Trial name
- NCT01604070
- Where
- 4 sites in United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- eMedtrain Inc.
Lower Extremity Surgery, Bunion
Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL, EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered as Combined Sciatic and Saphenous Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 120 subjects undergoing lower extremity surgeries.
- Conditions
- Lower Extremity Surgery, Bunion, Metatarsophalangeal Fushion, Midfoot Fusion
- Trial name
- STRIDE (NCT04518462)
- Testing
- Exparel, Bupivacaine Hydrochloride
- Where
- 5 sites in United States
- Volunteers
- 121 people
- Sponsor
- Pacira Pharmaceuticals, Inc