Clinical trials: Wound Management
Spinal Fractures, Vertebral Compression Fractures
SpineJack® Versus Conservative Treatment Study (SPICO Study)
This study will compare two standard treatments in acute stable traumatic vertebral fractures (types A1 and A3.1 by Magerl Classification). The two treatments are as follows: 1. SpineJack® system 2.
- Conditions
- Spinal Fractures, Vertebral Compression Fractures, Back Injuries, Trauma
- Trial name
- NCT02657265
- Testing
- SpineJack system, Conservative management
- Where
- 9 sites in France
- Volunteers
- 100 people
- Sponsor
- Vexim SA
Minor Traumatic Brain Injury (TBI)
Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion in Youth and Adolescents Athletes.
Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing changes in brain activity associated with concussion.
- Trial name
- NCT01923441
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- ElMindA Ltd
Urinary Retention, Neurogenic Bladder
Connected Catheter (C2P) Study for Bladder Management
The objective of this study is to evaluate the safety and essential performance of the C2P System in males with neurogenic lower urinary tract dysfunction (NLUTD), both in an acute clinical setting and an extended period of home…
- Trial name
- NCT03626324
- Testing
- C2P
- Where
- 8 sites in United States
- Volunteers
- 27 people
- Sponsor
- Spinal Singularity
Minor Traumatic Brain Injury (TBI)
Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion
Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing changes in brain activity associated with concussion.
- Trial name
- NCT01759173
- Where
- Canada
- Volunteers
- 234 people, healthy volunteers welcome
- Sponsor
- ElMindA Ltd
Abdominoplasty
Cohera TissuGlu® Surgical Adhesive in the Management of Wound Drainage
This study is designed to evaluate the safety and efficacy of the device while reducing the amount of drainage from surgical wounds following large flap surgical procedures, in this case abdominoplasty, as compared to the…
- Trial name
- NCT01526954
- Testing
- TissuGlu Surgical Adhesive
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Cohera Medical, Inc.
Burns, Burn Degree Second
A Study to Evaluate the Safety, Tolerability and Efficacy in Patients With Burn(s)
For Phase 1, researchers will explore the safety, and tolerability of PMS-101 and determine the recommended Phase 2 dose (RP2D) using the donor site.
- Trial name
- NCT06440239
- Testing
- PMS-101, Standard treatment
- Where
- Australia
- Volunteers
- 40 people
- Sponsor
- Primoris Therapeutics
Heart Failure, High Blood Pressure
BVA-200 vs BVA-100 Validation Study
The proposed study is a prospective, observational, investigator and patient blinded study comparing the results of blood volume measurement using the FDA-cleared Daxor BVA-100 device to the Daxor BVA-200 device.
- Conditions
- Heart Failure, High Blood Pressure, High Cholesterol, Anemia
- Trial name
- NCT06227819
- Testing
- BVA-200
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Daxor Corporation
Third Degree Burns, Diabetes
Study of ST266 in Diabetic Subjects With Deep Burns Managed With Skin Grafts
This study is a randomized, double blind, placebo controlled trial at a single site. The primary objective is to evaluate the safety of ST266 in diabetic subjects with deep burns.
- Trial name
- NCT01715012
- Testing
- ST266, Saline
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Noveome Biotherapeutics, formerly Stemnion
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.
Accidental Falls, Fractures
Clinical Evaluation of a Wireless Monitoring Device to Reduce Falls in the Elderly and Others at High Risk of Falling
Falls are a public health problem of significant social and economic significance. No primary intervention devices have been shown to be effective in reducing falls and associated injuries.
- Conditions
- Accidental Falls, Fractures, Injuries
- Trial name
- NCT00249743
- Testing
- FallSaver (formerly called NOCwatch)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- NOCwatch International
Wound
To Evaluate the Safety and Performance of the AMS ActivHeal Silicone Foam and the ActivHeal Silicone Foam Lite Dressing.
To demonstrate the safety and performance of both AMS ActivHeal Silicone Foam and AMS ActivHeal Silicone Foam Lite dressings to both the patient and clinician in managing both chronic and acute wounds.
- Trial name
- NCT04621838
- Testing
- Assigned interventions.
- Where
- Poland
- Volunteers
- 160 people
- Sponsor
- Advanced Medical Solutions Ltd.
Wounds, Leg Ulcers
The AutoloGel™ Post-Market Surveillance (TAPS) Program
AutoloGel™ Post-Market Surveillance Program Purpose:Evaluate the incidence of hematologic and immunologic adverse events, including coagulopathies in patients with wounds to which AutoloGel™ was applied.
- Conditions
- Wounds, Leg Ulcers, Pressure Ulcers, Diabetic Foot Ulcers
- Trial name
- TAPS (NCT00762138)
- Testing
- AutoloGel System
- Where
- 2 sites in United States
- Volunteers
- 131 people, healthy volunteers welcome
- Sponsor
- Cytomedix
Wound Healing, Diabetic Foot
EDX110 - Efficacy and Safety in the Management of Hard-to-heal Wounds
Post-market study to determine the efficacy of EDX110 dressing system in hard-to-heal wounds.
- Conditions
- Wound Healing, Diabetic Foot, Foot Ulcer, Diabetic, Venous Ulcer
- Trial name
- NCT06640985
- Testing
- EDX110 wound dressing system
- Where
- Chile
- Volunteers
- 43 people
- Sponsor
- ConvaTec Inc.
Wound of Skin
DermaClose DUKE Fasciotomy and Wound Study
To evaluate the clinical performance of DermaClose and DermaClose XL Continuous External Tissue Expander (CETE) devices to reduce wound size and/or assist with closure in acute full thickness wounds of the skin and assess the…
- Trial name
- NCT05330767
- Testing
- DermaClose Continuous External Tissue Expander Device, DermaClose XL Continuous External Tissue Expander Device, Conventional wound dressings
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Baxter Healthcare Corporation
Surgical Wound Infection, Traumatic Wound Infection
A Study of Amicidin-β Topical Solution for Patients With Surgical or Traumatic Wound Infections
The goal of this Phase 1 clinical trial is to learn about the safety profile of Amicidin-β topical solution applied directly into infected surgical or traumatic wounds during a surgical procedure.
- Trial name
- NCT07379684
- Testing
- Amicidin-β topical solution - 15 mL, Amicidin-β topical solution - 50 mL, Standard of Care (SOC)
- Where
- 5 sites in United States
- Volunteers
- 44 people
- Sponsor
- Macro Biologics, Inc.
Diabetic Foot Ulcer, Amniotic Membrane Placental Allograft
a Prospective, Multicenter, Randomized Controlled Trial, With a Non-randomized Sentinel Cohort, Evaluating the Efficacy of Bioxheal, a Single-layer Placental-derived Biologic in Nonhealing Diabetic Foot Ulcers
BIOxHEAL is an investigational placental-derived biologic being evaluated for the treatment of nonhealing diabetic foot ulcers. Adults with type 1 or type 2 diabetes who have a diabetic foot ulcer that has not healed with…
- Conditions
- Diabetic Foot Ulcer, Amniotic Membrane Placental Allograft, Biologic
- Trial name
- AB BIOH - DFU (NCT07852338)
- Testing
- Standard of Care, BIOxHEAL (human amniotic membrane allograft)
- Where
- United States
- Volunteers
- 253 people
- Sponsor
- Applied Biologics, LLC
Burn Wound
A Feasibility Study of a Novel Phototherapy System for the Management of Acute Burns
The primary purpose of this feasibility study is to evaluate safety and effectiveness in healing outcomes of patients treated with Lumina24TM BLU (treatment), a Continuous Low-Irradiance Phototherapy (CLIP) device, as compared to…
- Trial name
- NCT04011306
- Testing
- Lumina24 BLU
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Rogers Sciences Inc.
Post-operative Complications, Surgical Site Infection
The Use of the Prevena™ Incision Management System on Post-Surgical Cesarean Section Incisions
The purpose of this study is to compare the post-surgical standard-of-care dressing to the Prevena™ Incision Management System in women undergoing Cesarean section surgery.
- Conditions
- Post-operative Complications, Surgical Site Infection, Surgical Wound Infection
- Trial name
- NCT01450631
- Testing
- Prevena™ Incision Management System (PIMS), Standard-of-care Dressing
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- KCI USA, Inc
Pain
Study to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related Chronic Pain
The purpose of the study is to evaluate the efficacy and safety of OraVescent fentanyl treatment compared to placebo treatment monthly over a 12-week treatment period in alleviating breakthrough pain (BTP) in opioid-tolerant…
- Trial name
- NCT00343733
- Testing
- OraVescent Fentanyl
- Where
- 21 sites in United States
- Volunteers
- 120 people
- Sponsor
- Cephalon
Postmenopausal Osteoporosis
Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis
The purpose of this study is to provide 24 months of standard of care data on participants previously enrolled in Study BA058-05-003 (NCT02653417).
- Trial name
- ACTIVExtend (NCT01657162)
- Testing
- Alendronate
- Where
- 25 sites in United States, Argentina and 8 more
- Volunteers
- 1,139 people
- Sponsor
- Radius Health, Inc.