Clinical trials: Wound Complications
Diabetic Neuropathic Ulcer
Allogeneic ABCB5-positive Stem Cells for Treatment of DFU "Malum Perforans"
The aim of this clinical trial is to investigate the efficacy (by monitoring the wound surface area reduction of Diabetic Foot Ulcers) and safety (by monitoring adverse events) of two doses of the allogeneic investigational…
- Trial name
- NCT03267784
- Testing
- allo-APZ2-DFU
- Where
- 7 sites in Germany
- Volunteers
- 23 people
- Sponsor
- RHEACELL GmbH & Co. KG
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
Postoperative Pain, Hernia
A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair
This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local…
- Conditions
- Postoperative Pain, Hernia, Surgery
- Trial name
- NCT00974350
- Testing
- SABER-Bupivacaine
- Where
- 5 sites in Australia, New Zealand
- Volunteers
- 124 people
- Sponsor
- Durect
Diabetic Foot Ulcer, Venous Leg Ulcer
DETEC® Esterase for Screening Wound Infection at Point of Care
This non-interventional, single-blinded, prospective, observational study assesses the planar distribution of leukocyte esterase in wounds by placing wound exudates soaked wound dressings in the DETEC® Esterase device during…
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer
- Trial name
- NCT04614870
- Testing
- DETEC® Esterase
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Progenitec Inc.
Diabetic Foot Ulcer
Efficacy, Safety and Economic Benefits of Topical Wound Oxygen Therapy in the Treatment of Chronic Diabetic Foot Ulcers
The purpose of this study is to evaluate the efficacy, safety and economical benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of chronic diabetic foot ulcers.
- Trial name
- TWO2DFU (NCT02326337)
- Testing
- TWO2 Device
- Where
- 17 sites in United States, France and 3 more
- Volunteers
- 73 people
- Sponsor
- AOTI Ltd.
Acute Kidney Injury, ESRD
SAfety of Regional Citrate Anticoagulation (SARCA Study)
This is an Open-label, Prospective, Multicenter Study to Assess the SAfety of Regional Citrate Anticoagulation Delivered by the multiFiltratePRO system in Adult Patients Requiring Continuous Renal Replacement Therapy (SARCA…
- Trial name
- SARCA (NCT05339139)
- Testing
- Dialysis
- Where
- 10 sites in United States
- Volunteers
- 32 people
- Sponsor
- Fresenius Medical Care North America
Ischemia-reperfusion Injury
A Study to Evaluate the Safety and Pharmacokinetics of BX-001N in Healthy Participants
This is a randomized, double-blind, placebo-controlled, single and multiple ascending dose, Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of BX-001N after intravenous administration in approximately 64…
- Trial name
- NCT06097702
- Testing
- BX-001N Part 1, BX-001N Part 2
- Where
- Australia
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Bilix Co.,Ltd.
Diabetic Neuropathy, Painful, Diabetic Neuralgia
Study for Safety and Effectiveness of RWJ-333369 (Carsibamate) for the Treatment of Diabetic Peripheral Neuropathy (DPN).
The purpose of this study is to evaluate the safety, effectiveness, and tolerability of 200 mg of RWJ-333369 given twice daily by mouth compared with placebo in the treatment of Diabetic Peripheral Neuropathy (DPN).
- Conditions
- Diabetic Neuropathy, Painful, Diabetic Neuralgia, Diabetic Polyneuropathy, Diabetic Mononeuropathy
- Trial name
- NCT00501202
- Testing
- RWJ-333369 (carisbamate)
- Volunteers
- 132 people
- Sponsor
- SK Life Science, Inc.
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
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
Diabetic Foot, Ulcer Foot
SDRM® vs. Collagen for Diabetic Foot Ulcers
Supra SDRM® is FDA-cleared as a dressing for treating partial and full-thickness wounds. It is a dermal substitute that provides a barrier and an ECM-like structure to help accelerate wound healing.
- Conditions
- Diabetic Foot, Ulcer Foot, Wound Heal
- Trial name
- NCT05883098
- Testing
- Wound debridement, Wound closure matrix application
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Polymedics Innovations Inc.
Surgical Site Infection, Sternal Infection
D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery
Prospective, Multinational, Multicenter, Randomized, Parallel Controlled, Two arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SOC) IV Prophylactic…
- Conditions
- Surgical Site Infection, Sternal Infection, Cardiac Surgery
- Trial name
- NCT03558984
- Testing
- D-PLEX, Standard of Care
- Where
- 3 sites in United States, Israel
- Volunteers
- 2 people
- Sponsor
- PolyPid Ltd.
Diabetic Foot Ulcer (DFU), Diabetic Symmetrical Polyneuropathy
Comparative Study of Combination Treatment of Bionerv E+ Versus Vitamin B Complex in Treatment of Diabetic Polyneuropathy in Type 2 Diabetic Patients and Its Effect on Wound Healing
Diabetic symmetrical polyneuropathy (DSPN) is a common complication of diabetes that affects the nerves, especially in the legs and feet. It can cause pain, numbness, tingling, weakness, and loss of sensation.
- Trial name
- NCT07877948
- Testing
- Alpha-Lipoic Acid, Vitamin B1, Vitamin B6, Vitamin B12, Vitamin E, Vitamin B1, Vitamin B6, Vitamin B12
- Where
- Malaysia
- Volunteers
- 100 people
- Sponsor
- BREGO Life Sciences
Cardiac Surgery, Coronary Artery Bypass Grafting
Pharmacokinetics of AP214 Acetate in Patients Undergoing Cardiac Surgery
The purpose of the present research study is to investigate the pharmacokinetics, as well as safety, tolerability and pharmacodynamics of different ascending dosing regimens of AP214 in patients undergoing cardiac surgery.
- Conditions
- Cardiac Surgery, Coronary Artery Bypass Grafting, Valve Surgery, Aortic Root or Ascending Aortic Aneurysm Repair Surgery
- Trial name
- NCT00903604
- Testing
- AP214
- Where
- 2 sites in Denmark
- Volunteers
- 42 people
- Sponsor
- Action Pharma A/S
Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage
HEMOLEVEN® Expanded Access Program Prevention of Surgical/Postpartum Hemorrhage Severe Inherited Factor XI Deficiency
The objective of the Expanded Access Program is to provide HEMOLEVEN, a replacement coagulation factor XI, to patients with severe inherited factor XI deficiency where, in the opinion of the treating physician, the benefits of…
- Conditions
- Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage, Surgery
- Trial name
- EAP (NCT01701947)
- Testing
- Hemoleven
- Where
- United States
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
Surgical Wound Dehiscence
A Study, Performed in Subjects With Post Traumatic-post Surgical ,Venus Insufficiency and Diabetic Hard to Heal/Chronic Wounds, to Evaluate the Safety and Efficacy of PolyHeal-2 Versus PolyHeal in Once Daily Regimen
This is a double-blind , randomized, controlled, two-arm study aiming to evaluate the safety and efficacy of Polyheal-2 vs PolyHeal, in once daily application as compared to historical control.
- Trial name
- NCT01679678
- Testing
- PolyHeal 2, Polyheal
- Where
- 4 sites in Israel
- Volunteers
- 15 people
- Sponsor
- MediWound Ltd
Chronic Kidney Disease, Acute Kidney Injury
FAST GFR: Pilot Study to Evaluate the Safety of the FAST GFR Test in Patients.
This is a single site study designed to evaluate the FAST mGFR Test™ in healthy adult volunteers, patients with varying degrees of chronic kidney disease (CKD), and patients with acute kidney injury (AKI).
- Trial name
- NCT01978314
- Testing
- 75 mg / 6 mL VFI™
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- FAST BioMedical
Bronchopulmonary Dysplasia, BPD
Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial
This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants.
- Trial name
- NCT04003857
- Testing
- PNEUMOSTEM®, normal saline
- Where
- 2 sites in South Korea
- Volunteers
- 60 people
- Sponsor
- Medipost Co Ltd.
Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracoabdominal
Clinical Application of the Medyria TrackCath System in Endovascular Repair of Abdominal Aortic Aneurysms (AAA)
Pre-market, single-arm, prospective, open-label, multi-center clinical trial aimed at assessing the safety and the performance of the Medyria TrackCath system in patients undergoing endovascular intervention.
- Conditions
- Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracoabdominal, Acute Renal Failure, Acute Kidney Injury
- Trial name
- ACCESS (NCT04190979)
- Testing
- Medyria TrackCath System
- Where
- 4 sites in Germany
- Volunteers
- 40 people
- Sponsor
- Medyria AG
Surgical Site Infection
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
The aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1…
- Trial name
- POLYNOVO-CHD (NCT05966961)
- Testing
- Novosyn® in emergency or elective laparotomy or laparoscopic surgery, Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery
- Where
- 4 sites in Italy, Spain
- Volunteers
- 2,998 people
- Sponsor
- Aesculap AG