Clinical trials: Pressure Ulcers
Wounds and Injuries, Burns
Clinical Registry Collecting Real World Evidence on Wound Care Treatments
The proposed registry Sponsor (Siddhey LLC) will collect data on various wound treatments in real life settings. Data collection will facilitate the analysis of the safety and efficacy of wound treatments.
- Conditions
- Wounds and Injuries, Burns, Mohs Surgery, Diabetic Foot Ulcer Mixed
- Trial name
- SIDDX (NCT06328010)
- Testing
- Various types of wound care treatments
- Where
- 12 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- Siddhey 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
Dermatitis, Melanoma (Skin Cancer)
Using Artificial Intelligence to Help Doctors Identify Different Skin Conditions and Improve Patient Care
This study aims to determine if an artificial intelligence (AI) medical device can help doctors more accurately identify a wide variety of skin conditions and improve the efficiency of patient consultations.
- Conditions
- Dermatitis, Melanoma (Skin Cancer), Alopecia, Urticaria
- Trial name
- LegitHealthSAN (NCT07428954)
- Testing
- AI-based medical device for aided diagnosis in Dermatology
- Where
- Spain
- Volunteers
- 16 people
- Sponsor
- AI Labs Group S.L
Chronic Ulcers
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
This prospective, randomized, single-blind, controlled clinical investigation evaluates the efficacy and safety of ZKARE®, a topical polymeric gel dressing, and its accessory applicator ZKAPI®, for the treatment of chronic…
- Trial name
- NCT07406152
- Testing
- ZKARE®, Standard Wound Care
- Where
- Spain
- Volunteers
- 134 people
- Sponsor
- i+Med S.Coop.
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
Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs)
Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care
This clinical study is being conducted to evaluate how well the Miro3D Wound Matrix helps heal difficult wounds and ulcerations in an outpatient care setting.
- Conditions
- Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs), Pressure Ulcers, Surgical Wound Dehiscence (SWD)
- Trial name
- NCT06939673
- Testing
- Acellular Porcine-Derived Wound Matrix
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Reprise Biomedical, Inc.
Pressure Ulcers Stage II, Pressure Ulcers Stage III
Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries
Pressure injuries, commonly known as pressure ulcers, affect over 2.5 million people in the United States. Pressure injuries are classified into four escalating stages, from intact skin to full thickness wounds with deep tissue…
- Conditions
- Pressure Ulcers Stage II, Pressure Ulcers Stage III, Pressure Ulcer, Stage IV
- Trial name
- NCT05496296
- Testing
- Altrazeal® Transforming Powder Dressing
- Where
- 14 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- ULURU 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
Chronic Wounds, Venous Leg Ulcers (VLUs)
Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds
Chronic wounds constitute a significant global health burden, affecting millions of individuals and contributing to increased morbidity, diminished quality of life, and rising healthcare costs.
- Conditions
- Chronic Wounds, Venous Leg Ulcers (VLUs), Diabetic Foot Ulcers (DFUs), Arterial Ulcers
- Trial name
- NCT07223892
- Testing
- Amniotic Tissue Allograft
- Volunteers
- 600 people
- Sponsor
- Bardia Anvar
Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs)
HEAL-4: Real-World Effectiveness of 4 Amniotic Allografts Adjunctive to Standard Care in DFU, VLU, and PU
This retrospective multi-site observational cohort study uses electronic health records (EHR) from U.S. wound care centers to evaluate the effectiveness of four amniotic membrane allografts (Acesso DL, Acesso TL, Neostim DL…
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs), Pressure Ulcers, Bedsores, Decubitus Ulcer
- Trial name
- HEAL-4 (NCT07223515)
- Where
- 2 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Dynamic Medical Services dba Acesso Biologics
Pressure Ulcer, Diabetes Mellitus
A Study of GM-XANTHO in Pressure Ulcer Patients
This is a randomized, placebo-controlled, double-blind, 3-arm, single-center, phase IIa, parallel study to assess the efficacy, safety, and tolerability of topically applied 2.5%, 5% GM-XANTHO plus standard of care in patients…
- Trial name
- NCT05199077
- Testing
- GM-XANTHO
- Where
- Taiwan
- Volunteers
- 58 people
- Sponsor
- Xantho Biotechnology Co., LTD
Pressure Ulcer Prevention
Prevention of Pressure Ulcers by Effleurage With RIVADOUCE VEGETABLE SKINCARE OIL in Patients at Risk of Pressure Ulcers
This is a prospective, non-interventional, multicenter, post-market clinical follow-up (PMCF) study conducted in real-life conditions to assess the clinical performance and safety of RIVADOUCE VEGETABLE SKINCARE OIL in the…
- Trial name
- NCT07045480
- Where
- France
- Volunteers
- 252 people
- Sponsor
- Laboratoires RIVADIS
Pressure Injury, Fall Prevention
Clinical Investigation Evaluating the Use of NETSmart Solution , Incorporated to NETSoins Software, in the Care and Support of Elderly People Living in Nursing Homes
NETSmart software is designed to help doctors, nurses and care assistants adapt the care of elderly people living in nursing homes to the following risks: pressure injuries undernutrition interactions between different drugs…
- Conditions
- Pressure Injury, Fall Prevention, Undernutrition, Drug Interaction
- Trial name
- NETSMART DM (NCT07027358)
- Testing
- NETSmart software
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Teranga Software
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, 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
Chronic Wounds, Venous Leg Ulcer (VLU)
Evaluation of Cold Plasma in Chronic Wound Healing
The goal of this clinical trial is to evaluate the effectiveness of cold atmospheric plasma treatment in promoting the healing of chronic wounds in adult participants suffering from chronic wounds.
- Conditions
- Chronic Wounds, Venous Leg Ulcer (VLU), Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
- Trial name
- PLASANAGENESIS (NCT06964048)
- Testing
- Cold Atmospheric Plasma treatment
- Volunteers
- 66 people
- Sponsor
- Plasana Medical
Cutaneous Ulcer, Diabetic Ulcer
Dermacyte® Liquid for Treatment of Cutaneous Ulcers and Wounds
The objective of this study is to make Dermacyte Liquid available on an expanded access basis to treat cutaneous ulcers and wounds refractory to initial treatment or that do not have adequate alternative treatments.
- Conditions
- Cutaneous Ulcer, Diabetic Ulcer, Surgical Wound Dehiscence, Burns - Multiple
- Trial name
- NCT06730022
- Testing
- MTX-001 (Dermacyte Liquid)
- Where
- United States
- Sponsor
- Merakris Therapeutics
Diabetic Foot Ulcer, Venous Leg Ulcer
ChitoCare Medical Wound Healing Gel PMCF Study on Healing of Chronic Wounds
We are testing a gel intended for the protection and healing of chronic wounds as a support for standard therapy. The main component of the gel is chitosan, a natural polymer that has the ability to stop bleeding, has a positive…
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer
- Trial name
- CHITOCHRONIC (NCT05570877)
- Testing
- ChitoCare medical Wound Healing Gel
- Where
- 9 sites in Croatia, Slovenia
- Volunteers
- 92 people
- Sponsor
- Primex ehf
Stage IV Pressure Ulcer, Diabetic Foot Osteomyelitis
Expanded Access Program (EAP) STIMULAN VG
Individual (single) patient expanded access may be considered.
- Trial name
- EAPSTIMVG (NCT06808568)
- Testing
- STIMULAN VG
- Sponsor
- Biocomposites Ltd
Pressure Sore, Pressure Ulcer
EmoLED Medical Device Treatment of Second and Third Stage Pressure Ulcers
The present clinical study aims to verify the effectiveness and safety of the blue light photobiomodulation therapy with EmoLED medical device in supporting the reparative process of the area of the second and third stage…
- Conditions
- Pressure Sore, Pressure Ulcer, Pressure Ulcers Stage III, Pressure Ulcers Stage II
- Trial name
- RISE_UP (NCT05130814)
- Testing
- blue light photobiomodulation, cleansing, hyaluronic acid gauze plus polyurethane foam
- Where
- Italy
- Volunteers
- 48 people
- Sponsor
- Emoled