NCT07677761

Brief Summary

Pressure injuries are a significant health problem, often resulting from pressure, friction, and impaired tissue perfusion, and are particularly common in individuals in intensive care, those with immobility, and those with chronic diseases. The literature extensively addresses interventions such as pressure reduction, the use of appropriate support surfaces, wound care practices, and nutritional support in the prevention and treatment of pressure injuries. However, the role of manual therapies aimed at improving circulation and lymphatic flow, such as manual lymphatic drainage (MLD), in pressure injuries has been examined in a limited number of studies. This research aims to fill a significant gap in the literature by evaluating the potential effects of manual lymphatic drainage on reducing edema, improving tissue perfusion, and supporting the wound healing process in individuals with pressure injuries.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jul 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Jul 2026Dec 2026

First Submitted

Initial submission to the registry

June 19, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

June 19, 2026

Last Update Submit

June 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Effect of manual lymphatic drainage

    The primary aim of this study is to evaluate the effect of manual lymphatic drainage on the healing level of pressure injuries. Wound healing will be assessed considering the wound stage (Stage 1-2-3-4, unstageable stage, and deep tissue injury) and size (length\*width\*depth).

    3 months

Study Arms (2)

Manual lymphatic drainage group

ACTIVE COMPARATOR

Individuals will be randomly assigned to intervention and control groups in a 1:1 ratio via the website random.org. The Bates-Jensen Wound Assessment Tool will be administered to all individuals by the researchers. The size of the wound (length\*depth\*width) will be measured and recorded. Standard care will be applied to the control group. The experimental group will receive standard care along with manual lymphatic drainage according to the protocol below. Afterwards, the Bates-Jensen Wound Assessment Tool will be administered to all individuals by the researchers, and the size of the wound (length\*depth\*width) will be measured and recorded.

Other: Experimental

comparison group

ACTIVE COMPARATOR
Other: Control

Interventions

Individuals will be randomly assigned to intervention and control groups in a 1:1 ratio via the website random.org. The Bates-Jensen Wound Assessment Tool will be administered to all individuals by the researchers. The size of the wound (length\*depth\*width) will be measured and recorded. Standard care will be applied to the control group. The experimental group will receive standard care along with manual lymphatic drainage according to the protocol below. Afterwards, the Bates-Jensen Wound Assessment Tool will be administered to all individuals by the researchers, and the size of the wound (length\*depth\*width) will be measured and recorded.

Manual lymphatic drainage group
ControlOTHER

Standard care practices will include regular position changes for patients, use of supportive surfaces to reduce pressure, maintenance of skin integrity, and keeping the wound area clean. Wound cleaning will be performed with sterile solutions, appropriate debridement methods will be applied in the presence of necrotic tissue, and suitable dressing materials will be selected according to the condition of the wound bed. In addition, patients' nutritional status, hydration level, and signs of infection will be regularly assessed, and necessary supportive treatments will be provided.

comparison group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of pressure injury in the sacrum region
  • Volunteer to participate in the study
  • Being over 18 years of age
  • Being hospitalized in the anesthesia intensive care unit

You may not qualify if:

  • Chronic illness that may affect pressure injury healing (malnutrition, hypertension, and diabetes)
  • Discharge during the investigation process
  • Death during the investigation process
  • Acute cellulitis
  • Severe heart failure
  • Renal failure
  • Tuberculosis
  • Superior vena cava obstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

rukiye kökkız, LECTURER

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
LECTURER

Study Record Dates

First Submitted

June 19, 2026

First Posted

July 1, 2026

Study Start

July 1, 2026

Primary Completion

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share