Clinical trials: Foot Surgery
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
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
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
Diabetic Foot Ulcers, Diabetic Foot Wounds
Using Santyl on Diabetic Foot Ulcers
Subjects enrolled in this study will either use Santyl daily or follow standard care procedures for up to 6 weeks for their diabetic foot wound.
- Trial name
- NCT01408277
- Testing
- Santyl, Control
- Where
- 7 sites in United States
- Volunteers
- 55 people
- Sponsor
- Healthpoint
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
Postoperative Pain
Bunionectomy Study for Postoperative Analgesia (EPOCH 1)
This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in…
- Trial name
- NCT03295721
- Testing
- HTX-011, Bupivacaine HCl, Luer-lock applicator
- Where
- 15 sites in United States
- Volunteers
- 412 people
- Sponsor
- Heron Therapeutics
Leg Ulcer, Diabetic Foot Ulcer
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic…
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Trial name
- NCT01966380
- Testing
- Leia
- Where
- Sweden
- Volunteers
- 6 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Foot Ulcers, Foot Wounds
Santyl vs. Sharp Debridement of Diabetic Foot Wounds
This study tests two different approaches to the removal of dead tissue from the surface of a wound.
- Trial name
- NCT01056198
- Testing
- Santyl, Control
- Where
- 9 sites in United States
- Volunteers
- 48 people
- Sponsor
- Healthpoint
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
Wound
Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border
The clinical study will evaluate the safety and effectiveness of the ALLEVYN Gentle Border. The study is a post-market clinical follow-up to assess clinical performance and safety of ALLEVYN Gentle Border with new wound contact…
- Trial name
- NCT03877484
- Testing
- ALLEVYN Gentle border
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 43 people
- Sponsor
- Smith & Nephew Orthopaedics AG
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.
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
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
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
Procedural Sedation
A Safety Study of AQUAVAN® (Fospropofol Disodium) Injection for Sedation During Minor Surgical Procedures.
Very often patients receive medications before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation.
- Trial name
- NCT00327392
- Testing
- AQUAVAN® (fospropofol disodium) Injection
- Where
- 15 sites in United States
- Volunteers
- 123 people
- Sponsor
- Eisai Inc.
Pain, Post-operative
Evaluation of N1539 Following Bunionectomy Surgery
The primary objective of this study is to evaluate the analgesic efficacy of N1539 in subjects with acute moderate to severe pain following unilateral bunionectomy.
- Trial name
- NCT02675907
- Testing
- N1539
- Where
- 4 sites in United States
- Volunteers
- 201 people
- Sponsor
- Baudax Bio