Clinical trials: Foot Deformity
Bunionectomy, Hallux Valgus
Phase 3, Sciatic Nerve Block With EXPAREL for Subjects Undergoing Bunionectomy
The study is conducted sequentially in two parts. Part A: The purpose is to obtain information on pharmacokinetic (PK) profile, pharmacodynamics (PD), efficacy, safety, and to assess the performance of 266 mg EXPAREL vs 133 mg…
- Trial name
- NCT05157841
- Testing
- Bupivacaine liposome injectable suspension 266 mg, Bupivacaine HCl, Bupivacaine liposome injectable suspension 133 mg
- Where
- 7 sites in United States
- Volunteers
- 185 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Cerebral Palsy, Muscle Spasticity
Dysport® Pediatric Lower Limb Spasticity Study
The purpose of this research study is to determine whether Dysport® is effective in the treatment of increased stiffness of the calf muscles and to evaluate the safety of this treatment in children with Cerebral Palsy.
- Conditions
- Cerebral Palsy, Muscle Spasticity, Children
- Trial name
- NCT01249417
- Testing
- Botulinum toxin type A
- Where
- 29 sites in United States, Chile and 4 more
- Volunteers
- 241 people
- Sponsor
- Ipsen
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
Bunion, Hallux Valgus
Study of Postoperative Analgesia in Bunionectomy
After undergoing bunion surgery, patients are given a pain medicine injection that may last for up to several days or a placebo. Their pain and pain medicine use is then monitored.
- Trial name
- NCT00890682
- Testing
- SKY0402
- Where
- United States
- Volunteers
- 193 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Onychomycosis of Toenails
Efficacy and Safety of AN2690 Topical Solution to Treat Onychomycosis of the Toenail
The purpose of this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.
- Trial name
- NCT01302119
- Testing
- AN2690 Topical Solution, 5%, Solution Vehicle
- Where
- 32 sites in United States, Canada
- Volunteers
- 604 people
- Sponsor
- Pfizer
Bunion, Pain
Intravenous Tapentadol in Post-Bunionectomy Pain
The purpose of this trial is to established the safety and efficacy of multiple dose treatment with tapentadol IV in an adult population with moderate to severe pain following bunionectomy.
- Trial name
- NCT01435577
- Testing
- Tapentadol
- Where
- United States
- Volunteers
- 177 people
- Sponsor
- Grünenthal GmbH
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
Onychomycosis of Toenails
Efficacy and Safety Evaluation of AN2690 Topical Solution to Treat Onychomycosis of the Toenail
The purpose of this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.
- Trial name
- NCT01270971
- Testing
- AN2690 Topical Solution, 5%, Solution Vehicle
- Where
- 27 sites in United States
- Volunteers
- 594 people
- Sponsor
- Pfizer
Cerebral Palsy, Muscle Spasticity
Dysport® Pediatric Lower Limb Spasticity Follow-on Study
The purpose of this research study was to determine the long term safety and efficacy of repeated treatments with Dysport® used in the treatment of lower limb spasticity in children with dynamic equinus foot deformity due to…
- Conditions
- Cerebral Palsy, Muscle Spasticity, Children
- Trial name
- NCT01251380
- Testing
- Botulinum toxin type A
- Where
- 27 sites in United States, Chile and 4 more
- Volunteers
- 216 people
- Sponsor
- Ipsen
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
Hallux Valgus
Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples
This clinical investigation was led as a post-market clinical follow-up study (post-market device development stage). Therefore, its objectives were as follows: To assess functional clinical score's evolution, To evaluate…
- Trial name
- NCT05523219
- Where
- France
- Volunteers
- 81 people
- Sponsor
- Societe dEtude, de Recherche et de Fabrication
Pain, Postoperative, Bunion
Safety and Efficacy of COV795 in Moderate to Severe Post-Operative Bunionectomy Pain With an Open-label Extension
The primary objective of this study is to show the effectiveness of repeated doses of COV795 versus placebo, using the summed pain intensity difference over the first 48 hours in subjects with acute moderate to severe pain…
- Trial name
- NCT01484652
- Testing
- COV795
- Where
- 5 sites in United States
- Volunteers
- 329 people
- Sponsor
- Mallinckrodt
Arthralgia, Bunion
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of tapentadol (CG5503) compared with oxycodone and with placebo in subjects who have…
- Conditions
- Arthralgia, Bunion, Hallux Valgus, Pain
- Trial name
- NCT00613938
- Testing
- Tapentadol (CG5503), oxycodone
- Where
- 7 sites in United States
- Volunteers
- 901 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Bunions, Postoperative Pain
Dose-Escalation Study of HTX-034 Following Bunionectomy
This was a Phase 1b/2, randomized, blinded, active-controlled study. Phase 1b evaluated escalating doses of HTX-034 compared with bupivacaine HCl.
- Trial name
- NCT04398329
- Testing
- HTX-034 low dose, HTX-034 high dose, Luer lock applicator
- Where
- 4 sites in United States
- Volunteers
- 78 people
- Sponsor
- Heron Therapeutics
Hallux Valgus, Bunion
Early Weight-Bearing After the Lapiplasty Mini-Incision Procedure (Mini3D)
Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery.
- Trial name
- Mini3D (NCT05082012)
- Testing
- Treatment of Hallux Valgus
- Where
- 10 sites in United States
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Treace Medical Concepts, Inc.
Foot Deformities, Acquired, Disorder of Joint of Foot
A Clinical Study of Outcomes in Foot and Ankle Bone Grafting Using map3® Cellular Allogeneic Bone Graft
This is a single arm pilot study in patients requiring surgical fusion in the foot or ankle. Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
- Conditions
- Foot Deformities, Acquired, Disorder of Joint of Foot, Fracture of Foot, Deformity of Bone
- Trial name
- NCT02161016
- Testing
- map3
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- RTI Surgical
Hallux Limitus of Left Great Toe, Rheumatoid Arthritis
Mid-term Outcomes of First MTP Arthroplasty With Primus™ FGT Implant.
Foot silicone implants suffer from bad reputation on the market, due to poor results obtained with the first generations of implants.
- Conditions
- Hallux Limitus of Left Great Toe, Rheumatoid Arthritis, Arthritis of 1st Metatarsophalangeal Joint, Osteoarthritis
- Trial name
- NCT02350881
- Testing
- Primus FGTI (Flexible Great toe Implant)
- Where
- Italy
- Volunteers
- 70 people
- Sponsor
- Stryker Trauma and Extremities
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
Hallux Valgus
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy Compared With Placebo
The purpose of this study is to evaluate the analgesic efficacy and safety of tapentadol immediate-release (IR [CG5503]) for use in the relief of moderate to severe acute pain, compared with placebo, in adult Taiwanese patients…
- Trial name
- NCT01813890
- Testing
- Tapentadol IR 50 mg, Tapentadol IR 75 mg
- Where
- 3 sites in Taiwan
- Volunteers
- 60 people
- Sponsor
- Janssen-Cilag International NV
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