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Pressure Ulcer, Stage IV clinical trials

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NCT ID: NCT06283979 Not yet recruiting - Osteomyelitis Clinical Trials

A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.

BLADE OPU2
Start date: July 1, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only) for the treatment of osteomyelitis associated stage IV pressure ulcers.

NCT ID: NCT05496296 Recruiting - Clinical trials for Pressure Ulcers Stage III

Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries

Start date: April 30, 2023
Phase: N/A
Study type: Interventional

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 loss and exposed bone. This study will compare current standard of care treatment (as recommended by the National Pressure Injury Advisory Panel) to treatment with Altrazeal® in patients with stage 2, stage 3 and stage 4 pressure injury wounds. Altrazeal® is a Class 1, 501(k) exempt medical device listed with the FDA as a "dressing, wound, hydrogel" and has an extended wear time of up to 30 days. Subjects can be enrolled in the study either as an outpatient, or while hospitalized. Half of the subjects will be randomized to standard of care treatment, and the other half will be randomized to Altrazeal®. There are a total of up to 12 study visits taking place over 12 weeks.

NCT ID: NCT04311229 Completed - Clinical trials for Pressure Ulcers Stage III

Effectiveness of Negative-Pressure Wound Therapy

Start date: October 13, 2016
Phase: N/A
Study type: Interventional

This study aims to compare the effects of Negative-Pressure Wound Therapy and wet-to-dry dressing on Stages 3 and 4 pressure injuries, and to investigate the consistency of Three-Dimensional Wound Measurement Device findings with Pressure Ulcer Scale for Healing Tool scores. This study is a randomized controlled trial. A total of 30 patients with Stages 3 and 4 pressure injuries were included in the study. The patients were divided into two groups: the experimental group or Negative-Pressure Wound Therapy group and the control or wet-to-dry dressing group. All patients received 3 rounds of treatment. Data were collected with a Patient Identification Form, Pressure Ulcer Scale for Healing Tool and the findings of Three-Dimensional Wound Measurement Device. We found that granulation tissue formation was more significant in the experimental group (p < .05), and that there was more significant wound shrinkage (p < .05) with a more significant decrease in the Pressure Ulcer Scale for Healing Tool scores (p < .05). The wounds were assessed with the Tool and the Three-Dimensional Wound Measurement device. Device measurements were found to be correlated with Pressure Ulcer Scale for Healing Tool Tool findings (p < .05) There was a significant correlation between device-measured granulation findings and PUSH Tool score results of the experimental group's third measurements (p < .05). We conclude that Negative-Pressure Wound Therapy is an effective treatment method for pressure injuries, and Three-Dimensional Wound Measurement device is an usable wound assessment tool.

NCT ID: NCT03283787 Completed - Pressure Ulcer Clinical Trials

Comparing Concomitant Use of ACell MicroMatrix® and ACell Cytalâ„¢ to Standard of Care in Stage 3 or 4 Pressure Injuries

Start date: April 1, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate incidence of complete epithelialization in stage 3 & 4 pressure ulcers using ACell products.

NCT ID: NCT03038490 Recruiting - Clinical trials for Pressure Ulcers Stage III

The Use of an Oral Mixture of Arginine, Glutamine and Beta-hydroxy-beta-methylbutyrate for Treatment of Pressure Ulcers

Start date: December 1, 2016
Phase: N/A
Study type: Interventional

To investigate whether an oral nutritional supplement of a mixture of arginine, glutamine and HMB for a maximum period of four weeks is more beneficial than the standard dietary approach to the healing of pressure ulcers, and to examine whether the use of it can reduce admissions and length of hospitalizations for these patients.