Clinical trials: Pressure Sore
Diabetes, Neuropathic Limb
Novel Home Care Device for High-Risk Diabetic Patients
More than half of all lower extremity amputations are in persons with diabetes. These patients suffer from severe, diabetes-induced, peripheral, sensory neuropathy and, thus they frequently do not protect their feet from…
- Conditions
- Diabetes, Neuropathic Limb, Elevated Temperature, Shear Pressure
- Trial name
- TempTouchRM (NCT00500175)
- Testing
- TempTouchRM, Offloading
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Diabetica Solutions Inc.
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
Venous Leg Ulcer (VLU), Diabetic Foot Ulcer (DFU)
A Real World Data Collection of Human Amniotic Membrane(s) on Diabetic Foot Ulcers, Venous Leg Ulcers, Pressure Ulcers and Post Operative Wounds
This study is designed to evaluate the effectiveness of Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ compared to the effectiveness of Standard of Care alone though a retrospective data collection.
- Conditions
- Venous Leg Ulcer (VLU), Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
- Trial name
- NCT07078968
- Testing
- Tri-Membrane Wrap™, Membrane Wrap™, Membrane Wrap-Hydro™
- Where
- 4 sites in United States
- Volunteers
- 500 people
- Sponsor
- BioLab Holdings
Pressure Ulcer
Comparative Prevention-effectiveness Trial of DabirAIR Overlay System
Henry Ford Health System will evaluate the DabirAIR overlay system (DOS) for its effectiveness in preventing hospital acquired pressure ulcer (HAPU) in the peri-operative setting.
- Trial name
- NCT02565797
- Testing
- DabirAIR alternating pressure overlay
- Where
- United States
- Volunteers
- 392 people
- Sponsor
- Dabir Surfaces Inc
Pressure Ulcers
P400 for Stage II-IV Pressure Ulcers in Home and Extended Care
To assess the efficacy of a pressure ulcer treatment mattress, the P400 mattress, in the treatment of multiple Stage II or one or more large Stage III or IV pressure ulcers in the home care and extended care (nursing home)…
- Trial name
- P400 (NCT01139879)
- Testing
- P400 mattress
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Hill-Rom
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
Pressure Ulcer
Case Series of Weekly Applications of dHACM in Treatment of Pressure Ulcers
A prospective case series investigating the efficacy and safety of dehydrated human amnion/chorion membrane (dHACM) in the treatment of patients with Stage II or III pressure ulcers
- Trial name
- NCT02861560
- Testing
- dHACM
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- MiMedx Group, Inc.
Pressure Ulcer
PMCF Study on the Safety of Linovera Emulsion for the Prevention of Cat-1 Pressure Ulcers, Vascular and DFU
To assess the safety of Linovera® Emulsion in the prevention of Grade I Pressure ulcers, Vascular and Diabetic Foot Ulcers. To assess the performance of Linovera® Emulsion for the prevention of stage 1 Pressure Ulcers, Vascular…
- Trial name
- PRELINEM (NCT05763654)
- Testing
- Linovera emulsion
- Where
- Spain
- Volunteers
- 164 people
- Sponsor
- B. Braun Medical SA
Pressure Ulcer
Prevention of Pressure Ulcers in Patients at Medium to High Risk of Pressure Ulcers Using the R'GO SOINS Overlay Mattress
The aim of the study is to determine the clinical value of using a powered alternating pressure air overlay mattress (P-APAM) in the prevention of pressure injury (PI) in patients at medium to high risk.
- Trial name
- PRESERVE (NCT06465225)
- Testing
- Use of a powered alternating pressure air mattress
- Where
- France
- Volunteers
- 90 people
- Sponsor
- Nausicaa Medical
Patient Positioning, Monitoring, Physiologic
An Assessment of the Zephyr BioPatch and Its Ability to Monitor Patient Position
The primary objective of the study is to examine the effectiveness of the Zephyr BioPatch in measuring position changes of a non-patient subject in a lab setting and to examine the effectiveness of the Zephyr BioPatch in…
- Conditions
- Patient Positioning, Monitoring, Physiologic, Pressure Ulcer
- Trial name
- NCT02548624
- Testing
- Zephyr BioPatch
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Medtronic - MITG
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
Tissue Repair, Soft Tissue Reconstruction
Urinary Bladder Matrix (UBM) Registry
The purpose of this registry is to collect real-world information on patients treated with Urinary Bladder Matrix (UBM) products.
- Conditions
- Tissue Repair, Soft Tissue Reconstruction, Wound Management, Pressure Ulcer (PU)
- Trial name
- NCT07805798
- Testing
- Urinary Bladder Matrix (UBM) Products
- Volunteers
- 300 people
- Sponsor
- Integra LifeSciences Corporation
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
External Wounds Measured for Length by Width Using a Ruler
Measuring Wounds Found on the Outside of the Body Surface
The purpose of this study is to test wounds found on the outside of the body surface with an investigational medical imaging device that collects visual pictures and thermal digital pictures of the wound site.
- Trial name
- NCT01869439
- Testing
- "gold standard" LxW manual ruler measurement technique, WMMS ImageReview software's LxW measurement technique, WMMS ImageReview software's Visual External Wound Trace
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Wound Vision
Venous Leg Ulcer, Diabetic Foot Ulcer
EUREKA Italy - Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management
Multi-center, prospective, interventional, uncontrolled open-label study evaluating the real-life use of KLOX LumiHeal BioPhotonic System in chronic wounds management (venous leg ulcers, diabetic foot ulcers, pressure ulcers).
- Conditions
- Venous Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Trial name
- NCT03021811
- Testing
- KLOX LumiHeal BioPhotonic System
- Volunteers
- 100 people
- Sponsor
- KLOX Technologies Inc.
Decubitus Ulcer
Case Series Assessing TissuGlu® Surgical Adhesive in Flap Surgery for Decubitus Repair
To evaluate the impact of a high strength lysine-based adhesive (TissuGlu® Surgical Adhesive) on complications and revision rates in large flap surgery for decubitus repair.
- Trial name
- NCT03482999
- Testing
- TissuGlu Surgical Adhesive
- Volunteers
- 50 people
- Sponsor
- Cohera Medical, Inc.
Chronic Pressure Ulcers
PuraPly® AM Plus the Standard of Care to Standard of Care Alone for the Management of Stage II-IV Pressure Ulcers.
This is a prospective, multi-center, randomized, controlled clinical study Of PuraPly® AM and standard of care (SOC) compared to SOC alone for the management of Stage II-IV pressure ulcers located in the gluteal, ischial, hip…
- Trial name
- NCT03502824
- Testing
- PuraPly® Antimicrobial Wound Matrix, SOC for Pressure Ulcers
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Organogenesis
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.
Diabetic Foot Ulcers, Pressure Ulcers
Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds
To compare HP828-101 to standard of care for the management of partial or full thickness wounds
- Trial name
- NCT00971048
- Testing
- HP828-101, Hydrogel/Hydrocolloid
- Where
- 11 sites in United States
- Volunteers
- 88 people
- Sponsor
- Healthpoint
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