Clinical trials: Chronic Foot Ulcers
Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU)
Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing
The retrospective trial is observational, intended to stand alone, complement and integrate data collected in ongoing clinical studies to aid in establishing payor coverage in the United States (U.S.) for Cellution Biologics…
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU), Pressure Ulcer (PU)
- Trial name
- RETRO-PLAST (NCT07375160)
- Testing
- dHPT, AIC
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Cellution Biologics
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.
Critical Limb Ischemia
Dissolved Oxygen Dressing to Improve Chronic Wound Healing After Revascularization for Critical Limb Ischemia
A Prospective, Randomized, Single-center Pilot Study of The OxyGenesys(TM) Dissolved Oxygen Dressing to Improve Chronic Wound Healing after REvascularization for Critical Limb Ischemia.
- Trial name
- NCT02046226
- Testing
- Oxygenesys(TM) Dissolved Oxygen Dressing
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Halyard Health
Diabetic Foot Ulcer
Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers
This is a randomized controlled crossover trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating diabetic foot ulcers.
- Trial name
- NCT06938685
- Testing
- Standard of Care, NeoThelium FT
- Where
- 8 sites in United States
- Volunteers
- 132 people
- Sponsor
- NuScience Medical Biologics, LLC
Chronic Diabetic Foot Ulcers
Evaluate the Safety and Efficacy of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
The primary efficacy endpoint for this study is the proportion of subjects with complete closure of Target Ulcer during the 20-week Treatment Phase, which is assessed by the blinded independent evaluator.
- Trial name
- NCT04962139
- Testing
- ON101 Cream, Vehicle Cream
- Where
- 14 sites in United States
- Volunteers
- 12 people
- Sponsor
- Oneness Biotech Co., Ltd.
Diabetic Foot Ulcer
Safety and Efficacy Study of APIC-PRP in Non-healing Diabetic Foot Ulcers
Patients have a diabetic foot ulcer that is older than 4 weeks and has been treated with physician-selected standard of care treatment such as debridement, hydrogel or saline irrigation, primary dressing, and offloading will be…
- Trial name
- NCT02209662
- Testing
- APIC-PRP
- Volunteers
- 274 people
- Sponsor
- Cytonics Corporation
Chronic Wounds
Swab Sample Collection for the Detection of Bacterial Proteases
The objective of this study is to collect wound exudate (fluid) swab samples from Subjects who have wounds that show clinical signs of infection, as well as from Subjects who have wounds that do not show clinical signs of…
- Trial name
- NCT01881815
- Testing
- Swabs
- Where
- United States
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- Systagenix Wound Management
Chronic Diabetic Foot Ulcers
Study to Evaluate the Safety and Efficacy of CHAM* for the Treatment of Diabetic Foot Ulcers
A Multicenter, Randomized, Single-Blind Study with an Open-Label Extension Option to Further Evaluate the Safety and Efficacy of Cryopreserved Human Amniotic Membrane for the Treatment of Chronic Diabetic Foot Ulcers
- Trial name
- *OTI-15-01 (NCT02571738)
- Testing
- CHAM, Control
- Where
- 18 sites in United States
- Volunteers
- 108 people
- Sponsor
- Osiris Therapeutics
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.
Pressure Ulcer, Foot Ulcer, Diabetic
Use of Santyl Within an Accountable Care Organization
This study is designed to assess the comparative effectiveness of SANTYL® versus standard of care in the treatment of pressure ulcers and diabetic foot ulcers within the continuum of care of an ACO.
- Trial name
- NCT02716519
- Testing
- Santyl, Standard Care
- Where
- United States
- Sponsor
- Smith & Nephew, Inc.
Chronic Ulcer of Leg or Foot, Pressure Injury
A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Safety, and Performance of ConvaFoam™ Dressings in the Management of Indicated Chronic Wound Types.
A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoam™ dressings in the management of indicated chronic wound types.
- Trial name
- MORGEN (NCT05632250)
- Testing
- ConvaFoam
- Where
- 5 sites in United States
- Volunteers
- 95 people
- Sponsor
- ConvaTec Inc.
Foot Ulcer, Diabetic
Evaluation of a Medical Food for Chronic Wounds
The study objective is to compare outcomes in subjects with a diabetic foot ulcer after 16 weeks of consuming a medical food versus a calorically similar control drink.
- Trial name
- NCT00711217
- Testing
- Medical Food, Drink mix calorically similar to experimental product
- Where
- 51 sites in United States, Spain and 2 more
- Volunteers
- 271 people
- Sponsor
- Abbott Nutrition
Foot Ulcer, Diabetic, Diabetes Complications
Safety and Efficacy Study of MRE0094 to Treat Large, Single or Multiple, Chronic, Neuropathic, Diabetic Foot Ulcers
This is a clinical research study of an experimental topical drug for the treatment of chronic, neuropathic, diabetic foot ulcers.
- Trial name
- NCT00318214
- Testing
- MRE0094, Vehicle gel
- Where
- 19 sites in United States
- Volunteers
- 16 people
- Sponsor
- Pfizer
Chronic Diabetic Foot Ulcers
Soluble Beta-glucan (SBG) as Treatment for Diabetic Foot Ulcers
The purpose of this study is to determine whether the application of soluble beta-glucan (SBG) onto diabetic foot ulcers improves the healing of the ulcers.
- Trial name
- NCT00632008
- Testing
- Soluble beta-glucan (SBG)
- Where
- 11 sites in United Kingdom
- Volunteers
- 122 people
- Sponsor
- Biotec Pharmacon ASA
Diabetic Foot Ulcer
Randomized Clinical Study Assessing NuShield Versus Standard of Care in Diabetic Foot Ulcers
This prospective, multi-center, randomized, controlled clinical study compares NuShield® plus SOC to SOC alone in subjects with chronic DFUs.
- Trial name
- DFUs (NCT03855514)
- Testing
- NuShield
- Where
- 9 sites in United States
- Volunteers
- 200 people
- Sponsor
- Organogenesis
Foot Ulcer, Diabetic
Safety and Efficacy Study of Engensis (VM202) in the Treatment of Chronic Non-Healing Foot Ulcers
This study will assess the safety and efficacy of using gene therapy via intramuscular injections of the calf for patients with chronic non-healing foot ulcers.
- Trial name
- NCT02563522
- Testing
- Engensis (VM202)
- Where
- 22 sites in United States
- Volunteers
- 44 people
- Sponsor
- Helixmith Co., Ltd.
Diabetic Foot Ulcers (DFUs), Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing
This study is a prospective, randomized controlled trial designed to evaluate the effectiveness of Miro3D Wound Matrix plus Standard of Care (SOC) compared to SOC alone in treating Wagner Grade 1 diabetic foot ulcers (DFUs) and…
- Trial name
- STRIDDDE (NCT06939686)
- Testing
- Miro3D Wound Matrix, Standard of Care (SOC)
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Reprise Biomedical, Inc.
Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs)
Real-World Effectiveness of Amniotic Membrane Allografts Versus Standard Wound Care in DFU, VLU, and PU
This observational study will evaluate the real-world effectiveness of four amniotic membrane-based products (Zenith™, Orion™, SurGraft FT™, Complete ACA™) in addition to standard care, compared with standard care alone.
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs), Pressure Ulcers, Bedsores, Decubitus Ulcer
- Trial name
- NCT07223281
- Where
- 4 sites in United States
- Volunteers
- 2,400 people
- Sponsor
- Legacy Medical Consultants
Diabetic Foot Ulcer
Evaluating the Efficacy of OCM™ (Omeza® Complete Matrix) in the Treatment of Diabetic Foot Ulcers
This study aims to compare two treatment approaches for diabetic foot ulcers (DFUs): the standard of care (SOC) alone versus SOC combined with OCM.
- Trial name
- NCT07161830
- Testing
- Omeza® Complete Matrix, Standard of Care
- Where
- 10 sites in United States
- Volunteers
- 180 people
- Sponsor
- Omeza, LLC
Neuropathic Foot Ulcer, Foot Ulcer
Vaporous Hyperoxia Therapy (VHT) in the Treatment of Foot Wounds
The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT), previously named Misty (WTS-1000) for the treatment of chronic foot ulcers.
- Trial name
- VHT1 (NCT04244201)
- Testing
- Vaporous Hyperoxia Therapy
- Volunteers
- 31 people
- Sponsor
- Vaporox