Clinical trials: Skin Sores
Diabetic Foot Infection
PHOTOFINISH: a Clinical Study To Evaluate The Efficacy And Safety Of the System VULNOFAST® Plus/VULNOLIGHT® In Addition To The Usual Care (UC) Vs UC Alone For The Treatment Of Infected Diabetic Foot Ulcers
The aim of this randomised, open-label, multicentre clinical trial is to evaluate the superiority of the treatment which foresees the addition of the system VULNOFAST® plus / VULNOLIGHT® to the Usual Care, versus the treatment…
- Trial name
- PHOTOFINISH (NCT05613985)
- Testing
- Usual Care alone, System VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care
- Where
- 7 sites in Italy
- Volunteers
- 78 people
- Sponsor
- L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
Diabetes, Foot Ulcers
Evaluation of Negative Pressure Wound Therapy in the Treatment of DFUs Incl. Post Amputation Wounds.
Primary objective To assess wound healing and granulation tissue formation when using the NPWT system Secondary objectives To investigate the pain level at dressing removal To visually check exudate removal To investigate the…
- Trial name
- NCT01011387
- Testing
- NPWT System
- Where
- 2 sites in United Kingdom
- Volunteers
- 16 people
- Sponsor
- Molnlycke Health Care AB
Venous Leg Ulcer
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Therapy-resistant CVU (Phase III)
The aim of this clinical trial is to investigate the efficacy and safety of allo-APZ2-CVU, administered topically on therapy-resistant non-healing CVUs compared to placebo.
- Trial name
- NCT06489028
- Testing
- allo-APZ2-CVU
- Where
- 15 sites in United States, Austria and 10 more
- Volunteers
- 250 people
- Sponsor
- RHEACELL GmbH & Co. KG
Diabetic Foot Ulcer (DFU)
Exploring the Effect of Fespixon Cream for the Treatment of Diabetic Foot Ulcers (TEXAS 3A, 3B)
A Research Study to evaluate the therapeutic effect of Fespixon cream in patients suffering from DFU (UTWCS Grade III-A or III-B) by measuring the change of grade of UTWCS (University of Texas Diabetic Wound Classification…
- Trial name
- NCT05438251
- Testing
- Fespixon Cream
- Where
- Taiwan
- Volunteers
- 3 people
- Sponsor
- Oneness Biotech Co., Ltd.
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.
Diabetic Foot Ulcer
Omega3 Wound Fish Skin Graft in the Treatment of DFUs
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA-approved product that is derived from minimal processing of Atlantic cod fish skin: KerecisTM Omega3 Wound.
- Trial name
- NCT04133493
- Testing
- Kerecis Omega3 Wound, Fibracol
- Where
- 5 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Kerecis Ltd.
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
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
Venous Leg Ulcer (VLU)
A Multicenter, Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of a Soft Silicone Foam Dressing and to Evaluate the Performance of Standard Care in Exuding Venous Leg Ulcers
This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of Mölnlycke Health Care's quality system.
- Trial name
- NCT02167815
- Testing
- Mepilex XT, standard care
- Where
- 3 sites in Czechia
- Volunteers
- 30 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Foot Ulcer
Safety and Efficacy of HO/03/03 10μg in the Treatment of Plantar Neuropathic Diabetic Foot Ulcers
A prospective, double blind, randomized, placebo controlled, outpatient, parallel group comparison trial to assess the safety and efficacy of HO/03/03 10µg versus Placebo, applied topically once daily for up to 14 weeks in at…
- Trial name
- Truheal (NCT00926068)
- Testing
- HO/03/03 10µg
- Where
- 33 sites in United States, India
- Volunteers
- 196 people
- Sponsor
- HealOr
Wound Healing, Diabetic Foot
EDX110 - Efficacy and Safety in the Management of Hard-to-heal Wounds
Post-market study to determine the efficacy of EDX110 dressing system in hard-to-heal wounds.
- Conditions
- Wound Healing, Diabetic Foot, Foot Ulcer, Diabetic, Venous Ulcer
- Trial name
- NCT06640985
- Testing
- EDX110 wound dressing system
- Where
- Chile
- Volunteers
- 43 people
- Sponsor
- ConvaTec Inc.
Diabetic Foot
SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers (COVER DFUS II)
The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 1 diabetic foot ulcers.
- Trial name
- NCT06140303
- Testing
- SkinTE, Control
- Where
- 23 sites in United States
- Volunteers
- 100 people
- Sponsor
- PolarityTE
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.
Chronic Leg Ulcer, Chronic Diabetic Foot Ulcer
A PMCF Investigation on Chronic LU and DFU in Need of Debridement With ChloraSolv®
This is a single-arm, observational, multicenter PMCF investigation designed to confirm clinical performance and safety of ChloraSolv when exposed to larger population of clinical users.
- Trial name
- ChloraSolv02 (NCT04838600)
- Testing
- ChloraSolv
- Where
- 7 sites in Sweden
- Volunteers
- 34 people
- Sponsor
- RLS Global
Diabetic Foot Ulcer, Venous Leg Ulcer
PLASOMA Ultimate Safety & Efficacy Study
The purpose of the PULSE study are the followingL A.To perform post market clinical follow up (PMCF) on safety and efficacy: 1. Safety: To confirm transient short-terms side effects and verify long-term/outstanding risks. 2.
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Burn Wound
- Trial name
- PULSE (NCT04828304)
- Testing
- PLASOMA
- Where
- 6 sites in Netherlands
- Volunteers
- 101 people
- Sponsor
- Plasmacure
Diabetic Foot Ulcer, Amniotic Membrane Placental Allograft
a Prospective, Multicenter, Randomized Controlled Trial, With a Non-randomized Sentinel Cohort, Evaluating the Efficacy of Bioxheal, a Single-layer Placental-derived Biologic in Nonhealing Diabetic Foot Ulcers
BIOxHEAL is an investigational placental-derived biologic being evaluated for the treatment of nonhealing diabetic foot ulcers. Adults with type 1 or type 2 diabetes who have a diabetic foot ulcer that has not healed with…
- Conditions
- Diabetic Foot Ulcer, Amniotic Membrane Placental Allograft, Biologic
- Trial name
- AB BIOH - DFU (NCT07852338)
- Testing
- Standard of Care, BIOxHEAL (human amniotic membrane allograft)
- Where
- United States
- Volunteers
- 253 people
- Sponsor
- Applied Biologics, LLC
Diabetic Foot Ulcer
Efficacy of AutoloGel Therapy to Usual and Customary Care in Wagner gd 1 and 2 Diabetic Foot Ulcers.
The purpose of this study is to determine if AutoloGel platelet rich plasma used on non healing diabetic foot ulcers Wagner gd. 1 and 2 is more effective then the usual and customary care
- Trial name
- NCT01816672
- Testing
- AutoloGel, Usual and Customary Care
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Cytomedix
Chronic Ulcer of Lower Extremity
Safety and Preliminary Efficacy of PalinGen Flow Amniotic Tissue Allograft in Chronic Ulcers of the Lower Extremities
The purpose of this study is to assess the safety and preliminary efficacy of PalinGen® Flow for the treatment of chronic ulcers of the lower legs and feet.
- Trial name
- NCT04667416
- Testing
- PalinGen Flow Amniotic Tissue Allograft
- Where
- 7 sites in United States
- Volunteers
- 82 people
- Sponsor
- Amnio Technology, LLC
Pressure Injury, Venous Ulcer
MicroMatrix® Flex in Tunneling Wounds
To evaluate the safety and performance of MicroMatrix® Flex in subjects with wounds complicated by tunneling and/or undermining features.
- Conditions
- Pressure Injury, Venous Ulcer, Necrotizing Soft Tissue Infection, Diabetic Ulcers
- Trial name
- NCT06629506
- Testing
- MicroMatrix® Flex, MicroMatrix® UBM Particulate, Cytal® Wound Matrix 2-Layer
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Integra LifeSciences Corporation
Chronic Diabetic Foot Ulcer
Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers
The primary objective of this Phase 2 study is to evaluate the efficacy of DCB-WH1 ointment in wound closure as compared to vehicle control when applied topically to chronic diabetic foot ulcers for 12 weeks.
- Trial name
- NCT00709514
- Testing
- DCB-WH1 ointment
- Where
- Taiwan
- Volunteers
- 41 people
- Sponsor
- Oneness Biotech Co., Ltd.