Clinical trials: Foot Ulcer, Diabetic
Venous Leg Ulcer, Diabetic Foot
AQUACEL® Ag+ Extra™ and Cutimed™ Sorbact® Dressing in the Management of Venous Leg Ulcers Over a 12-week Period
Study is to provide evidence comparing AQUACEL® Ag+ Extra™ versus Cutimed® Sorbact® in the progression of wounds towards healing
- Trial name
- NCT05892341
- Testing
- AQUACEL® Ag+ Extra™, Cutimed® Sorbact®
- Where
- 18 sites in Colombia, Germany and 1 more
- Volunteers
- 203 people
- Sponsor
- ConvaTec Inc.
Wounds
Positive Predictive Value of the MolecuLight i:X Imaging Device to Predict the Presence of Bacteria in Chronic Wounds
This is a non-randomized evaluation for which 50 patients will be imaged at the Southwest Regional Wound Care Center, Lubbock, Texas, who present with a chronic wound and are receiving standard treatment.
- Trial name
- NCT02682069
- Testing
- MolecuLight i:X Imaging Device
- Volunteers
- 30 people
- Sponsor
- MolecuLight Inc.
Diabetic Foot Ulcer
The ASCEND Study: A Study to Investigate the Safety and Clinical Effect of Nexagon to Treat Slow Healing Diabetic Foot Ulcers
Diabetic foot ulcers are sores on the feet that occur in 15% of diabetic patients some time during their lifetime. Once an ulcer develops, the risk of lower-extremity amputation is increased 8-fold in people with diabetes.
- Trial name
- NCT00820703
- Testing
- Nexagon®, Nexagon® vehicle
- Where
- New Zealand
- Volunteers
- 24 people
- Sponsor
- OcuNexus Therapeutics, Inc.
Diabetic Foot Ulcer, Diabetes Mellitus
CSTC1 for Diabetic Foot Ulcers Phase II Study
The objective of this study is to evaluate the efficacy and safety of CSTC1 in patient with diabetic foot ulcers.
- Conditions
- Diabetic Foot Ulcer, Diabetes Mellitus, Wounds
- Trial name
- NCT01813305
- Testing
- CSTC1, CSTC1 Matched vehicle
- Where
- Taiwan
- Volunteers
- 124 people
- Sponsor
- Charsire Biotechnology Corp.
Diabetic Foot, Peripheral Arterial Disease
Hemodynamic Effects of Intramuscular PDA-002 in Subjects Who Have Diabetic Foot Ulcer With Peripheral Arterial Disease
Study PDA-002-DFU-003 is a Phase 2, multicenter, randomized, double blind, placebo-controlled, dose range finding study in subjects who have diabetic foot ulcer (DFU) with peripheral arterial disease (PAD).
- Trial name
- NCT02460081
- Testing
- PDA-002
- Where
- United States
- Sponsor
- Celularity Incorporated
Diabetic Foot Ulcer, Cutaneous Ulcer
Safety, Tolerability and Efficacy of CYP-006TK in Adults with Diabetic Foot Ulcers
Design: A randomised, controlled, prospective trial. Participants will be patients with non-healing diabetic foot ulcers. The study will aim to recruit 15 participants per study group (30 participants in total).
- Trial name
- NCT05165628
- Testing
- CYP-006TK
- Where
- 4 sites in Australia
- Volunteers
- 30 people
- Sponsor
- Cynata Therapeutics Limited
Venous Ulcers, Bedsores
HealiAid in the Treatment of Different Wounds
The goal of this open-label, post-market clinical follow-up study is to demonstrate the safety and effectiveness of HealiAid Collagen Wound Dressing in patients classified into different types of wounds: venous ulcers, bedsores…
- Conditions
- Venous Ulcers, Bedsores, Diabetic Foot Wound, Burn Wound
- Trial name
- NCT06280053
- Testing
- HealiAid Collagen Wound Dressing
- Volunteers
- 18 people
- Sponsor
- Maxigen Biotech Inc.
Foot Ulcer, Diabetic
NuShield/Affinity for the Treatment of Neuropathic Diabetic Foot Ulcers
This study was designed to determine the heal rate of diabetic foot ulcers at 4 weeks, and complete closure at 8 and 12 weeks of patients treated with either NuShield or Affinity compared to standard care alone.
- Trial name
- NCT02461641
- Testing
- NuShield, Affinity, Standard of Care
- Where
- 7 sites in United States
- Volunteers
- 96 people
- Sponsor
- NuTech Medical, Inc
Diabetic Foot Ulcer
Affinity Prospective Diabetic Foot Trial Crossover Group
This study is an extension of the randomized controlled trial NT-DFU-AFF-01. Subjects that were randomized to the Standard of Care group will be able to crossover to the NT-DFU-AFF-02 trial and receive Affinity fHSAM if certain…
- Trial name
- NCT03205436
- Testing
- Affinity human amniotic membrane
- Where
- 6 sites in United States
- Volunteers
- 20 people
- Sponsor
- Organogenesis
Diabetic Foot Ulcer
Evaluation of Safety of Low Level Laser Device Treatment in Chronic Wounds
This is a randomized, double blind, placebo-controlled study to evaluate the safety of the low level laser MC-8XL device treatment in subjects with an unsuccessfully treated Diabetic Foot Ulcer (DFU) that has been present for at…
- Trial name
- NCT03204149
- Testing
- MC-8XL low level laser device and Standard wound care
- Where
- Israel
- Volunteers
- 5 people
- Sponsor
- Medical Coherence LLC
Diabetic Foot Ulcer
Clinical Trial Evaluating the Safety and Efficacy of the Use of Chitosan Gel in Patients With Chronic Wounds
Type 1 and Type 2 diabetic patients with diabetic foot ulcer will be recruited and screened for participation in the study. Eligible patients will be randomized 1:1 to either experimental or control group and undergo 10-weeks of…
- Trial name
- CHITOWOUND (NCT04178525)
- Testing
- ChitoCare gel
- Where
- 5 sites in Croatia, Slovenia
- Volunteers
- 46 people
- Sponsor
- Primex ehf
Ulcer Healing, Diabetic Foot Ulcer
Evaluating The Efficacy Of A Keratin Graft In Treating Non-Healing Diabetic Foot Ulcers
The goal of this clinical pilot is to collect patient outcome data on a commercially available, keratin-based skin substitute matrix: ProgenaMatrix®.
- Trial name
- NCT05797285
- Testing
- human keratin graft
- Where
- 3 sites in United States
- Volunteers
- 26 people
- Sponsor
- ProgenaCare Global, LLC
Diabetic Foot Ulcer (DFU), Ulcer
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Diabetic Foot Ulcers
To prospectively evaluate the safety and efficacy of an Autologous Platelet-Rich Fibrin Plasma system when applied in conjunction with Standard of Care for management of chronic Diabetic Foot Ulcers.
- Conditions
- Diabetic Foot Ulcer (DFU), Ulcer, Wound Closure, Wound Management
- Trial name
- NCT07840378
- Testing
- PRFM, Standard of Care (SoC)
- Volunteers
- 55 people
- Sponsor
- Tiger Biosciences, LLC.
Leg Ulcer, Diabetic Foot Ulcer
Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice
This is a post - market study with a wound dressing, a CE-marked medical device available on the european market. The device will be used in routine clinical practice, i.e.
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer, Surgical Wound
- Trial name
- GELFI (NCT05148390)
- Testing
- Cutimed® Gelling Fiber
- Where
- Germany
- Volunteers
- 36 people
- Sponsor
- BSN Medical GmbH
Venous Leg Ulcer, Diabetic Foot
AQUACEL® Ag+ Extra™ vs Cutimed® Sorbact®
Study is to provide a blinded assessment of wound closure status utilizing photographs collected as per standard of care (SOC) during the AAA RCT (WC-22-435).
- Trial name
- NCT07308678
- Where
- Germany
- Volunteers
- 105 people
- Sponsor
- ConvaTec Inc.
Diabetic Foot Ulcer (DFU), Chronic Foot Ulcers
Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers
The purpose of this clinical investigation is to evaluate the safety and efficacy of Amnion/Chorion/Amnion allograft , Amnion/Chorion allograft, and/or Amnion/Amnion allograft, plus Standard of Care (SOC) each versus SOC alone in…
- Trial name
- NCT06681428
- Testing
- Allograft
- Where
- 9 sites in United States
- Volunteers
- 240 people
- Sponsor
- Tides Medical
Wound Heal, Ulcer
IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot Ulcers
A multi-center, prospective, observer-blinded, randomized controlled clinical trial to evaluate the efficacy of PPECM augmented standard of care versus standard of care alone in the management of hard-to-heal diabetic foot ulcers.
- Trial name
- IDEAL (NCT06616844)
- Testing
- InnovaMatrix® AC
- Where
- 21 sites in United States
- Volunteers
- 235 people
- Sponsor
- ConvaTec Inc.
Open Cracked Heel in Diabetic Patients With Polyneuropathy
Efficacy and Safety of V0111 Cream on Open Cracked Heel in Diabetic Patients With Polyneuropathy.
The purpose of this study is to evaluate the efficacy and the safety of the cream V0111 in the treatment of fissure(s) situated on the heels in diabetic patients with polyneuropathy.
- Trial name
- NCT02045199
- Testing
- Tested product : V0111 cream
- Where
- 20 sites in Belgium, France
- Volunteers
- 193 people
- Sponsor
- Pierre Fabre Medicament
Foot Ulcer, Diabetes
Safety and Efficacy Study of an Interactive Wound Dressing (KC002) for the Treatment of Diabetic Foot Ulcers
The objective of this study is to determine the safety and effectiveness of a device (the KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as compared with a conventional wound therapy…
- Trial name
- KC-002PT (NCT00330265)
- Testing
- KC-002, Conventional Wound Therapy
- Where
- 21 sites in United States
- Volunteers
- 300 people
- Sponsor
- KeraCure
Diabetic Foot Ulcer, Ulcer Foot
Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers
This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available treatments for diabetic foot wounds.
- Conditions
- Diabetic Foot Ulcer, Ulcer Foot, Diabetic Foot
- Trial name
- NCT06403605
- Testing
- Mirragen Advanced Wound Matrix, Fibracol
- Where
- 15 sites in United States
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- ETS Wound Care, LLC