Clinical trials: Diabetic Wounds
Diabetic Foot, Diabetic Foot Ulcer
SkinTE™ in the Treatment of Diabetic Foot Wounds
This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on a commercially available human autologous homologous skin construct with SOC dressing compared to SOC dressings…
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Ulcer Foot
- Trial name
- NCT03881254
- Testing
- Human Autologous Homologous Skin Construct, Additional Outer Dressing Applicaiton, Offloading
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- PolarityTE
Complex Diabetic Foot Wounds
GrafixCORE®: Open-Label Study to Evaluate the Safety and Efficacy of GrafixCORE® for Complex Diabetic Foot Wounds
A multicenter, open-label, single-arm study to evaluate the safety and efficacy of GrafixCORE® for the treatment of complex diabetic foot wounds with exposed tendon and/or bone.
- Trial name
- NCT02260609
- Testing
- Grafix®
- Where
- 4 sites in United States
- Volunteers
- 31 people
- Sponsor
- Osiris Therapeutics
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
Acute and Chronic Wounds, Pressure Ulcers
Clinical Evaluation of the SNaP Wound Care System
The purpose of this study is to assess the efficacy of design improvements of the Spiracur SNaP Wound Care System. This study prospectively evaluates the safety and efficacy of current and new design iterations of components of…
- Conditions
- Acute and Chronic Wounds, Pressure Ulcers, Trauma Wounds, Diabetic Foot Ulcers
- Trial name
- NCT01113658
- Testing
- SNaP Wound Care System
- Where
- 2 sites in United States
- Sponsor
- 3M
Wounds and Injuries, Negative Pressure Therapy
Comparison of Wound Healing Between MedCu Dressings With Copper Oxide and Negative Pressure Wound Therapy Treatment
Randomized multisite two arms study in which one arm of patients will be treated with Negative Pressure Wound Therapy (NPWT) known also as Vacuum-assisted closure (VAC) treatment ("VAC Arm") and the second arm of patients will be…
- Conditions
- Wounds and Injuries, Negative Pressure Therapy, Diabetic Foot Ulcer
- Trial name
- NCT05215730
- Testing
- MedCu wound dressings with copper oxide (COD)
- Where
- Israel
- Volunteers
- 46 people
- Sponsor
- MedCu Technologies Ltd.
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
Neurologic Disorders, Nervous System Diseases
Neurologic Stem Cell Treatment Study
This is a human clinical study involving the isolation of autologous bone marrow derived stem cells (BMSC) and transfer to the vascular system and inferior 1/3 of the nasal passages in order to determine if such a treatment will…
- Conditions
- Neurologic Disorders, Nervous System Diseases, Neurodegenerative Diseases, Neurological Disorders
- Trial name
- NEST (NCT02795052)
- Testing
- Intravenous and Intranasal BMSC
- Where
- 3 sites in United States, United Arab Emirates
- Volunteers
- 500 people
- Sponsor
- MD Stem Cells
Diabetes Mellitus, Ulcer Foot
Examining the Effectiveness of DermGEN™ in the Treatment of Diabetic Foot Ulcers in First Nations People
The study will examine the effectiveness of a decellularized dermal matrix (i.e., DermGEN™) in improving wound healing, quality of life and associated costs of treatment of DFUs in First Nations people living in the Northwestern…
- Conditions
- Diabetes Mellitus, Ulcer Foot, Ulcer Healing, Diabetic Foot Ulcer
- Trial name
- NCT05251480
- Testing
- Standard of Care, DermGEN™
- Where
- Canada
- Volunteers
- 120 people
- Sponsor
- DeCell Technologies Inc.
Hard to Heal Wounds, Venous Leg Ulcers
Efficacy and Safety Study of EscharEx to Treat (Debride) Hard to Heal Wounds
The main objective of this study is to assess the safety and the efficacy of EscharEx in preparing the wound's bed in patients with hard to heal venous leg ulcers, diabetic lower extremity ulcers and traumatic/post operative…
- Conditions
- Hard to Heal Wounds, Venous Leg Ulcers, Diabetic Lower Extremity Ulcers, Traumatic/ Post Operative Wounds
- Trial name
- NCT02020746
- Testing
- EscharEx, Gel Vehicle
- Where
- 8 sites in Israel
- Volunteers
- 111 people
- Sponsor
- MediWound Ltd
Pressure Ulcer, Venous Ulcer
PuraPly™ Antimicrobial Wound Matrix and Wound Management
The PuraPly Antimicrobial Wound Matrix (PuraPly AM) case series is a prospective, observational study for patients who have received PuraPly AM which consists of a collagen sheet coated with polyhexamethylenbiguanide…
- Conditions
- Pressure Ulcer, Venous Ulcer, Diabetic Ulcer, Surgical Wound
- Trial name
- PuraPlyAM (NCT03070938)
- Testing
- PuraPly™ Antimicrobial Wound Matrix
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Organogenesis
Diabetic Foot Ulcer of Neuropathic Origin
The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Northern Europe The TRANS-North Study
Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken Pharmaceutical Co., Ltd. (Tokyo, Japan).
- Trial name
- TRANS-North (NCT01217476)
- Testing
- Trafermin 0.01% spray
- Where
- 37 sites in Belgium, Bulgaria and 8 more
- Volunteers
- 207 people
- Sponsor
- Olympus Biotech Corporation
Wound Heal, Diabetic Foot Ulcer
EDX110 Randomized Control Trial for Treatment of DFUs
Prospective, multi-centered, observer blinded, pre-market study, 1:1 randomized control trial, to determine if addition of EDX110 dressing system to standard of care leads to an improvement in diabetic foot ulcers healing…
- Trial name
- NCT07209358
- Testing
- EDX110
- Where
- 10 sites in United States, Puerto Rico
- Volunteers
- 300 people
- Sponsor
- ConvaTec Inc.
Wounds and Injuries, Burns
ACTICOAT™ for the Treatment of Burns and Chronic Wounds
The aim of the study is to evaluate participant reported quality of life, safety, and overall performance with ACTICOAT in a clinical setting.
- Conditions
- Wounds and Injuries, Burns, Pressure Ulcer, Foot Ulcer
- Trial name
- NCT02852148
- Testing
- ACTICOAT
- Where
- 3 sites in United Kingdom
- Volunteers
- 25 people
- Sponsor
- Smith & Nephew, Inc.
Real Life Study, TLC-NOSF Dressings
Clinical Evaluation in Real Life of TLC-NOSF Dressings in the Local Treatment of Chronic Wounds (DFU and VLU)
The objective of this study is to document the performance and the safety of UrgoStart Plus® Border, UrgoStart Plus® Pad and UrgoStart Interface® in the local treatment of diabetic foot ulcers (neuropathic or neuroischemic …
- Conditions
- Real Life Study, TLC-NOSF Dressings, Venous Leg Ulcer, Diabetic Foot Ulcer
- Trial name
- STARTLIFE (NCT06135987)
- Testing
- TLC-NOSF dressings (D'URGOSTART PLUS® BORDER, URGOSTART PLUS® PAD and URGOSTART INTERFACE®)
- Where
- France
- Volunteers
- 600 people
- Sponsor
- Laboratoires URGO
Wound Healing
Efficacy Study of a Bioelectric Dressing Used With Negative Pressure Wound Therapy to Treat Diabetic and Pressure Ulcers
The purpose of this study is to determine whether a bioelectric wound dressing, used in conjunction with Negative Pressure Wound Therapy (NPWT), is effective in the treatment of diabetic and pressure ulcers of the foot.
- Trial name
- NCT01022216
- Testing
- Procellera™ Wound Dressing with V.A.C.® Therapy, V.A.C.® Therapy
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Vomaris Innovations
Pressure Ulcer, Diabetic Foot Ulcer
An Open, Non-comparative, Multicenter Investigation to Evaluate the Safety and Performance of Exufiber Ag+, a Gelling Fiber Silver Dressing, When Used in Medium to High Exuding Chronic Wounds
An open, non-comparative, multicenter investigation to evaluate the safety and performance of Exufiber Ag+, a gelling fiber silver dressing, when used in medium to high exuding chronic wounds
- Conditions
- Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer
- Trial name
- NCT05494450
- Testing
- ExufiberAG+
- Where
- 2 sites in United States
- Volunteers
- 46 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Foot Ulcer, Venous Leg Ulcer
The Avelle® Negative Pressure Wound Therapy System on Chronic Wounds
This study seeks to demonstrate the performance of Negative Pressure Wound Therapy on chronic wounds such as diabetic foot ulcers and venous leg ulcers.
- Trial name
- SPACE (NCT05666570)
- Testing
- Avelle NPWT
- Where
- Colombia
- Sponsor
- ConvaTec Inc.
Diabetic Foot Ulcer, Infection
Topical PluroGel PN for the Treatment of Mildly Infected Diabetic Foot Ulcers
This is an open label study of subjects who have failed Protocol PGN-1300. Adult subjects (greater than 18 years old) who present with a mildly infected diabetic foot ulcer (IDSA criteria) having full thickness (i.e., through the…
- Trial name
- NCT02119754
- Testing
- Plurogel PN
- Where
- 15 sites in United States
- Volunteers
- 15 people
- Sponsor
- PluroGen Therapeutics, Inc
Diabetic Foot Ulcer, Venous Leg Ulcer
Real World Evidence with the Debritom+ TM Novel Micro Water Jet Technology At a Single Wound Center
Prospective, single-blinded, single-center, parallel group, randomized controlled trial (RCT) to assess rate and frequency of wound healing and associated financial savings, when using Medaxis debritom+ versus standard of care as…
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Surgical Wound Dehiscence, Traumatic Wounds
- Trial name
- EVIDENT (NCT04920253)
- Testing
- Study Device Debridement, SOC Debridement
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Medaxis, LLC
Non-healing Wound
Treatment of Wounds Using Oasis® ECM
The purpose of this clinical study is to gather post-market clinical evidence on the use of Oasis ECM as a treatment for donor site wounds in the community setting in the United Kingdom.
- Trial name
- NCT03632031
- Testing
- Oasis Extracellular Matrix, Standard Care (in control arm)
- Where
- 2 sites in United Kingdom
- Volunteers
- 41 people
- Sponsor
- Cook Biotech Incorporated