Clinical trials: Lower Extremity Wound Infected
Infections, Infected Wound
PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics.
- Conditions
- Infections, Infected Wound, Nonunion of Fracture, Injury Leg
- Trial name
- POvIV2 (NCT05699174)
- Testing
- Standard of Care PO (oral) antibiotics, Standard of Care Intravenous (IV) antibiotics
- Where
- 13 sites in United States
- Volunteers
- 250 people
- Sponsor
- Major Extremity Trauma Research Consortium
Diabetes, Wound Infection
Tissue Penetration of Ceftolozane/Tazobactam in Diabetic Patients With Lower Limb Infections
This study will determine the tissue penetration of ceftolozane/tazobactam (Zerbaxa, Merck \& Co.), a novel β-lactam/β-lactamase combination antibiotic, into the extracellular, interstitial fluid of soft tissue in diabetic…
- Conditions
- Diabetes, Wound Infection, Healthy Volunteers
- Trial name
- NCT02620774
- Testing
- Ceftolozane/tazobactam, Microdialysis Catheter Insertion
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Hartford Hospital
Diabetic Foot Ulcer
A RCT to Compare the Effects of Two Wound Products on Biofilm Disruption in DFUs
This study is a prospective comparative study to determine if an Iodine Gel (Iodosorb◊) is better than standard dressing (Solosite◊ gel) in disruption of biofilm (small microorganism bacteria similar to plaque on teeth) on the…
- Trial name
- NCT02181621
- Testing
- Iodosorb, Solosite gel
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Smith & Nephew, Inc.
Diabetic Foot Ulcer, Non-healing Diabetic Foot Ulcer
EPC Silver Wound Gel (EPC-123) Feasibility Study in the Management of Mildly Infected Diabetic Foot Ulcers
The objective of this single-arm feasibility study is to investigate the safety and impact of the topical EPC Silver Wound Gel (EPC-123) in the management of diabetic foot ulcer wounds not progressing under the current standard…
- Conditions
- Diabetic Foot Ulcer, Non-healing Diabetic Foot Ulcer, Diabetic Foot Infection
- Trial name
- NCT05243810
- Testing
- EPC Silver Wound Gel
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- Exciton Technologies Inc.
Lower Limb Ischaemia, Aneurysm
Bacterial Growth in Vascular Surgery Wounds
The amount and species of bacteria have been shown to have an effect in wound infections in several fields of surgery (such as gastrointestinal and orthopaedic surgery and the surgery of facial area).
- Trial name
- NCT01505738
- Testing
- bacterial samples
- Where
- Finland
- Volunteers
- 100 people
- Sponsor
- North Karelia Central Hospital
Diabetic Foot Ulcer
A Prospective Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AC
This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BioREtain® Amnion Chorion (BR-AC) plus standard of care versus standard of care only in the treatment of diabetic foot…
- Trial name
- NCT06511596
- Testing
- BR-AC, Standard Care
- Where
- 11 sites in United States
- Volunteers
- 71 people
- Sponsor
- BioStem Technologies
Toenail Fungal Infection, Cellulitis
A Subjective Observational Study of Patients Using Medicated Footbath/Footwash Treatment in Podiatry Care
The purpose of this study is to evaluate the level of relief perceived by patients using medicated footbath/footwash with or without an oral medication for the treatment of podiatry issues.
- Conditions
- Toenail Fungal Infection, Cellulitis, Pitted Keratolysis, Diabetic Foot Ulcer
- Trial name
- NCT03781024
- Testing
- Footwash
- Where
- United States
- Volunteers
- 5,000 people
- Sponsor
- Data Collection Analysis Business Management
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
Hypovitaminosis D
Vitamin D Status in Lower Extremity Joint Replacement Surgery Patients
In the United States, ~1 million elective hip or knee replacement surgeries are performed annually. With estimated surgical site infection (SSI) rates as high as 2.5%, this represents ~25,000 patients at risk of potentially…
- Trial name
- NCT01858051
- Testing
- Cholecalciferol
- Where
- United States
- Sponsor
- Massachusetts General Hospital
Diabetes, Wound Infection
Tebipenem (SPR994) Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis
This study will determine the tissue penetration of a broad-spectrum orally bioavailable carbapenem, tebipenem pivoxil hydrobromide (SPR994) (Spero Therapeutics, Inc.), into the extracellular, interstitial fluid of soft tissue in…
- Conditions
- Diabetes, Wound Infection, ABSSSI, Healthy Volunteers
- Trial name
- NCT04919954
- Testing
- Tebipenem Pivoxil Hydrobromide
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Hartford Hospital
Surgical Site Infection
PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)
The purpose of this study is to see whether applying povidone iodine (PVI) to the noses of patients undergoing lower extremity (leg, ankle, or foot) orthopedic fixation procedures of high-energy lower extremity fractures (HELEF)…
- Trial name
- POTENT (NCT05763602)
- Testing
- povidone-iodine topical ointment
- Where
- 6 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Loreen Herwaldt
Peripheral Vascular Disease
Lower Extremity Regional Anesthesia and Infrainguinal Bypass Grafting
In this investigation, the investigators will attempt to demonstrate that patients who have received nerve blocks (regional anesthesia) prior to open surgical vascular bypass of the lower extremities (infrainguinal bypass…
- Trial name
- NCT01803165
- Testing
- Single shot femoral and sciatic nerve block
- Sponsor
- University of Nebraska
Wound Infection, Fractures, Open
Tobramycin Injection to Prevent Infection in Open Fractures
The goal of open extremity fracture (OEF) treatment is to promote fracture healing and restore function while preventing the development of infection.
- Conditions
- Wound Infection, Fractures, Open, Surgical Site Infection
- Trial name
- NCT04964947
- Testing
- Tobramycin Injection
- Where
- 3 sites in United States
- Volunteers
- 600 people
- Sponsor
- Massachusetts General Hospital
Diabetic Foot
Cold Plasma Therapy for Acceleration of Wound Healing in Diabetic Foot
Diabetic foot is a common complication of diabetes mellitus and requires specialized treatment. Wounds are characterized by persistent infection and chronic inflammatory processes, impeding well directed matrix remodelling and…
- Trial name
- NCT04205942
- Testing
- Argon Plasma Jet
- Volunteers
- 65 people
- Sponsor
- Ruhr University of Bochum
Carbohydrate Ingestion
Role of Low Carbohydrate Nutrient in Healing of Infected Diabetic Foot
A low-carbohydrate diet, when combined with standard wound care and diabetes management, appears to accelerate the healing of infected diabetic foot, improve blood glucose control, reduce systemic inflammation and promoting…
- Trial name
- LCN (NCT06759688)
- Testing
- Carbohydrates restriction
- Where
- Egypt
- Volunteers
- 120 people
- Sponsor
- Sarah Magdy Abdelmohsen
Surgical Wound Infection
Prophylactic Negative Wound Pressure Therapy (PICO-7) Following Groin Incisions in Vascular Surgery (PICO-Vasc Study)
Comparison between waterproof sterile dressing OPSITE Post-Op Visible, Smith \& Nephew, UK and PICO-7, Smith \& Nephew, UK in terms of inguinal surgical wound infection and complications after lower limb revascularization.
- Trial name
- PICO-Vasc (NCT04840576)
- Testing
- Regular waterproof sterile dressing., Prophylactic Negative Pressure Dressing
- Where
- Spain
- Volunteers
- 132 people
- Sponsor
- Corporacion Parc Tauli
Arterial Obstructive Diseases
Trial Using Integuseal as Microbial Sealant for Arterial Bypass Surgery on Lower Extremities
The purpose of this study is to prove a reduction of postoperative wound infections after direct preoperative use of a microbial sealant in the form of Integuseal for vascular procedures on lower extremities.
- Trial name
- ITT (NCT00940979)
- Testing
- Application of Integuseal sealant
- Where
- 3 sites in Netherlands
- Volunteers
- 450 people
- Sponsor
- Rijnstate Hospital
Infection, Surgical Site
Use of Real-time Fluorescence Imaging in Diabetic Foot Ulcers: the Impact of Colonization
The study evaluates the efficacy of fluorescence-guided de-colonization in patients with non-infected diabetic foot ulcers. The efficacy will also be compared between those who used artificial dermis and split-thickness skin…
- Trial name
- NCT05873049
- Testing
- MolecuLight
- Where
- Taiwan
- Volunteers
- 210 people
- Sponsor
- Taipei Medical University Shuang Ho Hospital
Vascular Disease, Surgery
Clinical Trial of a Silver Eluting Dressing System
This prospective, multi-institutional randomized clinical trial of a silver ion eluting dressing material compared to standard dry gauze for closed skin incisions after open surgical revascularizations for peripheral vascular…
- Trial name
- SILVER (NCT01229358)
- Testing
- Surgical dressing
- Where
- 3 sites in United States
- Volunteers
- 500 people
- Sponsor
- Brigham and Women's Hospital
Wound Infection, Amputation Wound
The Amputation Surgical Site Infection Trial (ASSIT)
Lower limb amputations are performed usually as a last resort in patients with acute and chronic limb ischaemia (CLI) caused by vascular disease, poorly controlled diabetes or, infection.
- Trial name
- ASSIT (NCT02018094)
- Testing
- Co-amoxiclav, Iodine, Metronidazole
- Where
- United Kingdom
- Volunteers
- 160 people
- Sponsor
- Hull University Teaching Hospitals NHS Trust