Clinical trials: Lower Extremity Wound
Impaired Wound Healing, Venous Insufficiency of Leg
Clinical Trial to Evaluate Blister Graft Utilizing a Novel Harvesting Device for Treatment of Venous Leg Ulcers
Epidermal grafts are believed to promote healing by two mechanisms: graft take and the promotion of wound healing through the delivery of growth factors and the essential elements of tissue repair and wound healing.28 This study…
- Conditions
- Impaired Wound Healing, Venous Insufficiency of Leg, Diabetic Ulcers
- Trial name
- Cellutome (NCT02148302)
- Testing
- Harvesting Device (CelluTome©)
- Where
- 18 sites in United States
- Volunteers
- 123 people
- Sponsor
- SerenaGroup, Inc.
Varicose Ulcer
Predictive of Biomarkers of Healing in Chronic Venous Ulceration of the Lower Limb
Chronic venous ulceration of the lower limb poses a significant problem to patients and healthcare providers alike. 1% of the population of Western countries have either an open or healed chronic venous ulcer.
- Trial name
- MOJITO (NCT01998932)
- Where
- 2 sites in United Kingdom
- Volunteers
- 28 people
- Sponsor
- Imperial College London
Diabetic Foot Ulcer
Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU)
This is a Phase 2a Multi-Center, Prospective, Randomized, Controlled Study aimed to evaluate the Safety and Efficacy of Topically Applied PEP-TISSEEL in Subjects with Diabetic Foot Ulcers (DFU)
- Trial name
- NCT06319287
- Testing
- PEP (Purified Exosome Product) / TISSEEL
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Rion Inc.
Thrombosis, Venous
A Study to Evaluate the Efficacy and Safety of Fondaparinux for the Prevention of Venous Blood Clots in Patients With a Plaster Cast or Other Type of Immobilization for a Below-knee Injury Not Needing Surgery
The purpose of this study is to evaluate the efficacy and safety of fondaparinux in comparison with a heparin (nadroparin) in preventing deep vein thrombosis (blood clots in the leg veins), whether symptomatic or detected by…
- Trial name
- FONDACAST (NCT00843492)
- Testing
- Fondaparinux sodium, Nadroparin
- Where
- 122 sites in France, Germany and 4 more
- Volunteers
- 1,351 people
- Sponsor
- GlaxoSmithKline
Amputation, Amputation; Postoperative, Sequelae
Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications
This study is a prospective, multi-center, two-arm, unblinded, and randomized controlled trial with a goal of evaluating the impact of a closed incision negative pressure dressing (PREVENA) on incidence of post-operative wound…
- Conditions
- Amputation, Amputation; Postoperative, Sequelae, Wound Dehiscence, Seroma
- Trial name
- PREVENA-AMP (NCT03773575)
- Testing
- PREVENA™ PEEL & PLACE™ Dressing Kit
- Where
- 3 sites in United States, Italy
- Volunteers
- 272 people
- Sponsor
- Thomas Jefferson University
Infection; Diabetic Foot
Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061)
This study compared ertapenem sodium to piperacillin/tazobactam sodium for the treatment of moderate to severe diabetic foot infections.
- Trial name
- NCT01370616
- Testing
- Ertapenem sodium, Piperacillin/tazobactam sodium, Amoxicillin/clavulunate potassium
- Volunteers
- 565 people
- Sponsor
- Merck Sharp & Dohme LLC
Diabetic Foot Ulcer
A Prospective, Randomized, Double-Blind Multicenter Study Comparing CDO Therapy to Standard MWT in the Treatment of DFUs
The purpose of this study was to evaluate the safety and effectiveness of Continuous Diffusion of Oxygen (CDO) therapy for the treatment of Diabetic Foot Ulcers.
- Trial name
- NCT01645891
- Testing
- CDO electrochemical tissue oxygenation system, Moist Wound Therapy
- Where
- 33 sites in United States
- Volunteers
- 146 people
- Sponsor
- Electrochemical Oxygen Concepts, Inc.
Metatarsal Stress Fracture, Stress Fracture of Tibia
Photobiomodulation Therapy for the Treatment of Lower Extremity Stress Fractures in a Military Training Setting
The goal of this clinical trial is to compare photobiomodulation therapy (PBMT) in addition to standard of care in the treatment of tibial and metatarsal bone stress injuries in a military training setting.
- Trial name
- PM12 (NCT05843864)
- Testing
- Photobiomodulation Therapy with Standard Physical Therapy
- Where
- United States
- Volunteers
- 103 people
- Sponsor
- Brooke Army Medical Center
Diabetes, Diabetic Foot Ulcer
Electrical Stimulation to Accelerate Wound Healing
A clinical study at the Baylor College of Medicine, Division of Vascular Surgery and Endovascular Therapy, is being proposed to test the efficacy of a novel electrical stimulation platform named the Tennant Biomodulator designed…
- Conditions
- Diabetes, Diabetic Foot Ulcer, Peripheral Neuropathy, Peripheral Arterial Disease
- Trial name
- NCT03821675
- Testing
- Electrical Stimulation - Active
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Baylor College of Medicine
Abscess, Wound Infection
Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection
Patients, who are considered suitable by their physicians to take part in this research, will have a physical examination (including an Electrocardiogram (ECG)), blood and urine samples taken, as well as a sample of the…
- Conditions
- Abscess, Wound Infection, Diabetic Foot, Ulcer
- Trial name
- NCT00402727
- Testing
- Moxifloxacin (Avelox, BAY12-8039), Piperacillin/Tazobactam & Amoxicillin/Clavulanic acid
- Where
- 123 sites in Austria, Belgium and 18 more
- Volunteers
- 813 people
- Sponsor
- Bayer
Diabetic Foot Ulcer
Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)
The primary objective of this study is to determine the outcomes of patients who receive a certain type of skin substitute called RestrataTM Wound Matrix (Restrata™).
- Trial name
- NCT03312595
- Testing
- Restrata TM Wound Matrix
- Where
- 5 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Acera Surgical, Inc.
Diabetic Foot Ulcers
Evaluating the Ease of Use of a VAC GranuFoam Bridge Dressing on Diabetic Foot Ulcers Receiving VAC Negative Pressure Wound Therapy
The study is aimed at evaluating the clinician's perceived ease of using the V.A.C. GranuForm bride dressing and the patients perceived level of comfort during the dressing wear.
- Trial name
- NCT00847730
- Testing
- V.A.C. Negative Pressure Wound Therapy System
- Where
- 6 sites in United States
- Volunteers
- 33 people
- Sponsor
- KCI USA, Inc
Diabetic Foot Ulcers
Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers
Have indolent diabetic ulcers completely healed by the Acellular Porcine Dermal Matrix (APM) in 12 weeks.
- Trial name
- NCT01353495
- Testing
- APM Graft (BIOTAPE XMTM), Wound Debridement
- Where
- 2 sites in United States
- Volunteers
- 39 people
- Sponsor
- Stryker Trauma and Extremities
Diabetic Foot Ulcer, Peripheral Arterial Disease
A Non-significant Risk Clinical Study of Therapeutic Ultrasound for Patients With Diabetic Foot Ulcers.
This study is evaluating whether a therapeutic ultrasound device can improve blood flow to the leg with diabetic foot ulcer (DFU).
- Conditions
- Diabetic Foot Ulcer, Peripheral Arterial Disease, Wound; Foot
- Trial name
- Dulcet (NCT05145439)
- Testing
- VibratoSleeve Therapeutic Ultrasound Device
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Vibrato Medical, Inc.
Upper Extremity Wound, Lower Extremity Wound
VAC Bioburden Wound Care Assessment
The purpose of this study is to compare the microbiologic burden and need for further operative debridement of patients undergoing primary surgical debridement of infected tissue, soft tissue abscesses, or traumatic wounds of the…
- Conditions
- Upper Extremity Wound, Lower Extremity Wound, Soft Tissue Abscesses, Traumatic Wounds
- Trial name
- NCT04826965
- Testing
- Wound Vac is applied
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Duke University
Venous Leg Ulcers, Diabetic Foot Ulcers
Single-Use Negative Pressure Wound Therapy System vs. Traditional Negative Pressure Wound Therapy System (tNPWT)
The aim of this study is to compare the clinical efficacy of two types of NPWT systems; the traditional negative pressure wound therapy (tNPWT) system and the single-use negative pressure wound therapy (PICO) system.
- Trial name
- NPWT (NCT02470806)
- Testing
- PICO System, tNPWT System
- Where
- 17 sites in United States, Canada
- Volunteers
- 164 people
- Sponsor
- Smith & Nephew, Inc.
Fractures, Open, Wounds and Injuries--Infections
Acute Application of Antibiotic Powder in Open Fracture Wounds
The purpose of this study is to help determine the best treatment for severe injures like open fracture wounds. Some broken bone injuries can be more likely to get an infection. It is mostly due to the way they were injured.
- Conditions
- Fractures, Open, Wounds and Injuries--Infections, Anti-Bacterial Agents, Fractures, Bone
- Trial name
- APOW (NCT04872400)
- Testing
- Vancomycin, Tobramycin
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- University of Colorado, Denver
Sarcoma, Cancer
Incisional Negative Pressure Wound Therapy for Preoperatively Irradiated Lower Extremity Soft Tissue Sarcoma Wounds
This is a study comparing two methods of dressing a post operative wound that are currently in practice. One method is a traditional dry gauze dressing.
- Conditions
- Sarcoma, Cancer, Infectious Disease
- Trial name
- NCT02638298
- Testing
- Prevana Dressing, Standard Dry Gauze Dressing
- Where
- United States
- Volunteers
- 163 people
- Sponsor
- Medical University of South Carolina
Wound Heal
Enhanced Secondary Intention Healing vs. Standard Secondary Intention Healing in Mohs Surgical Defects on the Head and Distal Lower Extremities
The purpose of this study is to elucidate if a novel biomaterial containing gelatin, manuka honey, and hydroxyapatite enhances secondary intention healing when compared to conventional secondary intention healing for surgical…
- Trial name
- NCT04545476
- Testing
- Participants in this group will receive the experimental APIS Biomaterial on the Head., Participants in this group will receive the experimental APIS Biomaterial on the Lower Extremities., Standard Secondary Intention Healing on the Head
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Vanderbilt University Medical Center
Varicose Ulcer
MIST Ultrasound Therapy Compared to United Kingdom Standard Care for the Treatment of Non-healing Venous Leg Ulcers
Chronic venous leg ulcers (VLUs) impact negatively on patients' quality of life. Standard treatment in the UK for patients with VLUs is compression bandaging or stockings.
- Trial name
- NCT01671748
- Testing
- MIST ultrasound therapy, Standard Care
- Where
- United Kingdom
- Volunteers
- 47 people
- Sponsor
- Cardiff and Vale University Health Board