Pressure Ulcer

15

Review clinical trials related to Pressure Ulcer. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers

Pilot observational clinical evaluation assessing the safety and potential effectiveness of THERAVEX Tissue Care Spray Plus as an adjunctive topical therapy for the management of cutaneous wounds, burns, traumatic lesions, pressure ulcers, diabetic ulcers, and chronic ulcers in 26 patients. The study evaluated wound healing progression, epithelialization, tissue hydration, inflammatory response, tolerance, and overall clinical evolution in patients receiving standard wound care combined with topical application of THERAVEX Tissue Care Spray Plus. Preliminary observations demonstrated favorable tissue response, progressive epithelial regeneration, reduction of inflammatory signs, and absence of treatment-related adverse events.

Participants needed: 26
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Biointelligent Technology Systems SLUpdated: Jun 4, 2026Locations: 1
Eligibility criteria

Not listed

Status: Recruiting

Efficacy of HOFA Versus Hydrocolloid Dressings in the Prevention of PUs in Critically Ill Prone Patients

Introduction: Prone position (PP) treatment as a rescue strategy for patients with acute respiratory distress syndrome (ARDS) is a technique increasingly used in our daily practice and, as a result of the current health situation due to SARS COV-2, has become the treatment of choice for many patients. Many of the associated complications can be considerably reduced with the implementation of standardized procedures and a team trained and specialized in this technique and its subsequent care. Aim: To evaluate the efficacy of the use of Hyperoxygenated Fatty Acids (HOFA) compared to the use of hydrocolloid dressings (HCD) in the prevention of Pressure ulcers (PUs) occurrence in critically ill patients in prone position. Methods: A randomized clinical trial will be conducted to compare the occurrence of PUs and other complications in patients undergoing PP in the ICU of the HUPHM. Two care groups will be formed in which HOFA and hydrocolloid dressings will be used, respectively, following a strict care protocol previously established in the unit. In addition, other variables related to medical and nursing treatment that may influence the appearance of PUs and other complications associated with PP will also be analyzed. Scientific relevance: PUs have a major socioeconomic and quality of life impact on patients. Dressings and topical agents for prevention are widely used, however, it is unclear which treatment is most effective in preventing PUs in the prone patient. Keywords: Prone Position; Nursing care; Pressure ulcer; Fatty acids; Prevention; Complications.

Participants needed: 262
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Puerta de Hierro University HospitalUpdated: May 15, 2026Locations: 1
Eligibility criteria

Not listed

Status: Recruiting

A Multicenter, Prospective, Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care Versus Matched Controls in the Management of Nonhealing Pressure Ulcers

A multicenter, prospective, clinical trial evaluating a single-layer amniotic membrane (XPURT) and standard of care versus matched controls in the management of nonhealing pressure ulcers.

Participants needed: 100
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Applied Biologics, LLCUpdated: Feb 11, 2026Locations: 1
Eligibility criteria

The potential subject must be at least 18 years of age or older. [+5]

The potential subject is known to have a life expectancy of < 3 months. [+17]

Status: Recruiting

PMCF Study of Debridement Pad

The design of the study is a clinical trial of Debridement Pad in subjects with superficial, chronic and acute wounds consisting of Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by secondary intention, traumatic or surgical wounds and burns and scalds. The performance data from this study will support clinically meaningful rates of successful improvement in wound bed condition immediately after treatment.

Participants needed: 184
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Advanced Medical Solutions Ltd.Updated: Dec 1, 2025Locations: 1
Eligibility criteria

Males or females aged 18 years or above. [+6]

Patients who are known to be non-compliant with medical treatment [+6]

Status: Not yet recruiting

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 with stage II or stage III pressure ulcer.

Participants needed: 58
Trial details
Phase: Phase 2Age: 20+Biological sex: AllType: InterventionalSponsor: Xantho Biotechnology Co., LTDUpdated: Sep 3, 2025Locations: 1
Eligibility criteria

1. Female or male inpatients including in those staying in a long-term care faci... [+10]

1. Surgical treatment of pressure ulcers within 30 days prior to the Screening V...

Status: Recruiting

A Real-World Registry of Chronic Wounds and Ulcers

WOUNDJOURNEY is a longitudinal, real-world, observational registry designed to capture the full clinical course and patient journey associated with chronic wounds and ulcers. Data are collected during routine care from over 1,400 clinicians across the USA and Puerto Rico using a highly structured certified electronic health record (EHR) or electronic data capture (EDC) system. Data are transmitted daily to the U.S. Wound Registry (USWR), a CMS-recognized Qualified Clinical Data Registry (QCDR). The registry captures real-time, research-ready data on patient demographics, comorbidities, wound characteristics, standard-of-care treatments, complications, and advanced therapeutics. It supports robust, fit-for-purpose real-world evidence generation by enabling risk-adjusted outcome analysis, comparative effectiveness research, and quality improvement across diverse sites of care.

Participants needed: 300,000
Trial details
Biological sex: AllType: ObservationalSponsor: U.S. Wound RegistryUpdated: Jul 16, 2025Locations: 1Duration: 5 Years
Eligibility criteria

Presence of one or more chronic wounds or ulcers of any etiology [+5]

Status: Recruiting

Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Matched Standard of Care Controls in the Management of Nonhealing Pressure Ulcers

The purpose of this study it to evaluate several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus matched standard of care controls in the management of nonhealing pressure ulcers.

Participants needed: 500
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Tiger Biosciences, LLC.Updated: Jun 5, 2025Locations: 1
Eligibility criteria

The potential subject must be at least 18 years of age or older. [+5]

The potential subject is known to have a life expectancy of < 3 months. [+15]

Status: Recruiting

PROSENIOR. Prevention of Pressure Ulcers, Malnutrition, Poor Oral Health and Falls Among Older Persons Receiving Municipal Health Care and Are Registered in the Quality Registry Senior Alert

Inclusion criteria for study I and II is nurse aides, registered nurses and managers working in nursing homes who register in Senior Alert. To develop an intervention aiming to reduce the risk of pressure ulcers, malnutrition, poor oral health and falls among older persons in nursing homes, workshops will be conducted in collaboration with nurse aides, registered nurses and managers (study I). Cluster randomization is going to take place via a computerized program prior to the workshops meaning that only those nurse aides, registered nurses and managers working in nursing homes allocated to the intervention group are going to develop an intervention together with the research group and then test it (study II). The remaining nurse aides, registered nurses and managers working in nursing homes in the control group continue with regular care.

Participants needed: 330
Trial details
Biological sex: AllType: InterventionalSponsor: Malmö UniversityUpdated: May 9, 2025Locations: 1
Eligibility criteria

Nursing homes registering in Senior Alert, which is a national quality registry

not meetin inclusion criteria

Status: Recruiting

Polyurethane Foam-Pink Pad (RCT) Use in OR

King Abdullah medical city has a cardiac center, and a lot of open-heart surgeries are performed there, and both polyurethane foam (pink Pad) and Mepilex dressing are applied to those patients. Therefore, the present study was designed to compare the effects of polyurethane foam (pink Pad) versus Mepilex dressing for prevention of pressure ulcer in operating room.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: King Abdullah Medical CityUpdated: Jan 24, 2025Locations: 1
Eligibility criteria

Subjects ≥ 18. [+4]

Subjects under 17 [+3]

Status: Recruiting

The ROTAtional-USE of Interface STUDY

In this trial investigators will explore if a protocolized rotational use of interfaces i.e., masks, during noninvasive positive pressure ventilation (NPPV) compared to standard care is clinically effective and cost-effective in reducing the incidence of pressure sores in patients with hypercapnic acute respiratory failure (AHRF) treated continuously i.e., for more than 24 hours, with NPPV (to avoid intubation, as alternative to invasive ventilation and after early extubation and weaning).

Participants needed: 478
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Azienda Ospedaliero Universitaria Maggiore della CaritaUpdated: Nov 14, 2024Locations: 1
Eligibility criteria

Age>18 years old [+1]

Patient with skin breakdown or non-blanchable erythema in one of the following a... [+12]

Status: Recruiting

The Effect of Pressure Ulcer Care Package on the Risk of Pressure Ulcer Development

This study aimed to determine the effect of pressure ulcer care package use on the risk of pressure ulcer development due to surgery in patients undergoing orthopedic surgery. It was planned as a randomized controlled study. The population of the study will consist of patients who underwent surgery in the Orthopaedics and Traumatology Clinic of Doğubayazıt Dr.Yaşar Eryılmaz State Hospital Hospital Hospital of Ağrı Provincial Health Directorate. The sample of the study will consist of patients who volunteered to participate in the study that meets the inclusion criteria. To obtain research data, the Personal Information Form developed by the researcher in line with the literature, 3S Operating Theatre Pressure Wound Risk Assessment Scale, Pressure Wound Regions and Stages Monitoring Form prepared according to NPUAP (2016) Pressure Wound Staging System Form will be used. Statistical analysis of the data obtained from the study will be performed using the SPSS 25 (Statistical Package of Social Science) package program.

Participants needed: 102
Trial details
Age: 18-70Biological sex: AllType: InterventionalSponsor: Cukurova UniversityUpdated: Aug 23, 2024Locations: 1
Eligibility criteria

Orthopaedics and traumatology department [+3]

Patients with pre-operative pressure ulcer [+3]

Status: Not yet recruiting

Combined Molecular and Mechanistic Methods for Detection of Pressure Ulcers

This project aims to develop a novel method for identifying early tissue damage related to pressure ulcer (PU) development in vulnerable patients by measuring biomarkers of inflammation on the skin surface. PUs are common and costly injuries that result from prolonged pressure on the skin. Current methods to assess PU risk are unreliable, and the mechanisms of PU development are not well understood. This project contributes to new knowledge of PU etiology as well as the individual variability at a molecular level combined with new knowledge about nursing actions and clinical factors linked to PU progression and outcomes of prevention. The project will use non-invasive techniques and model-based analysis to identify specific biomolecules that reflect individual susceptibility to pressure exposure in different PU risk scenarios.

Participants needed: 150
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Linkoeping UniversityUpdated: Jun 21, 2024Locations: 1
Eligibility criteria

acute respiratory failure [+2]

Status: Recruiting

Prevention of Pressure Ulcers in Patients at High Risk of Developping Pressure Ulcers Using the Low-pressure Motorized Air Support Mattress With XTECH®25 Control Unit

The aim of the study is to determine the clinical value of using a a low air pressure motorised therapeutic mattress in the prevention of pressure injury (PI) in patients at medium to high risk. This study is noncomparative, observational study. Patients older than 18 years of age, with a high risk of PI, without PI, lying more than 20 hours a day on a XTECH®25 mattress will be included. The study will be conducted in nursing homes, and in long-stay geriatrics department. Patients are followed up for 35 days. The use of the XTECH®25 mattress is associated with the usual PI prevention measures. The primary outcome is the percentage of patients who developed between day 0 and day 35 at least one PI of at least stage 2 on the sacrum, spine, or heel. Secondary endpoints are patient assessments of comfort, caregiver satisfaction, mattress noise level, and mattress safety.

Participants needed: 80
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: SYSTAMUpdated: Jun 18, 2024Locations: 1
Eligibility criteria

Patient over 18 years old [+5]

Patient at end of life (estimated life expectancy less than 6 months) [+9]

Status: Not yet recruiting

IDEAL SKIIN CARES Bundle to Prevent Pressure Injury

The study will be a multi-center, triple-blinded, cluster randomized controlled trial (c-RCT) conducted with a three-arm parallel design and a 1:1:1 allocation ratio. The experimental groups will consist of two arms: the intervention group, where patients will receive training in relevant pressure injury care bundles, and the placebo group, where patients will receive training in an irrelevant topic like respiratory care. Both intervention and placebo groups will receive specialized pressure injury prevention (PIP) care bundle from trained wound specialist nurses (WSNs). The third arm will be the control group comprising patients who do not undergo any training course and will receive only routine standard care for PIP care bundle. The aim of c-RCT will be to compare the incidence of hospital-acquired pressure injury (HAPI) in the three study groups and to provide detailed evidence on the effect of the developed pressure injury care bundle, administered by WSNs on the development of HAPI in trained hospitalized patients, as opposed to those receiving routine standard care for PIP care bundle without training.

Participants needed: 1,620
Trial details
Age: 18-90Biological sex: AllType: InterventionalSponsor: Baqiyatallah Medical Sciences UniversityUpdated: Apr 17, 2024
Eligibility criteria

be adults aged 18 years or older; [+2]

patients with significant pre-existing skin conditions or injuries that make it... [+6]

Status: Recruiting

Treatment of Osteomyelitis-associated Pressure Ulcers by Surgical Flaps and Anti-bacterial Agents

People with neuromotor disability (i.e. following an inborn or acquired spinal cord, cerebral or peripheral neurological lesion) are at high risk of osteomyelitis-associated pressure ulcers. The management of osteomyelitis-associated pressure ulcers is controversial. In our center, patients benefit from a one stage surgical management with bone shaving and flap covering osteitis of pressure ulcer to perform wound closing. Surgery is followed by an antibiotic treatment, secondarily adapted to intraoperative samples. The aim of this study is to describe the cohort and to identify factors associated with failure (or success) in this frail population.

Participants needed: 400
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Institut de Sante Parasport Connecte SynergiesUpdated: Feb 21, 2023Locations: 1
Eligibility criteria

Patients >= 18 years old ; [+5]

Under court protection.