Pressure InjuriesNCT07677761
Manual Lymphatic Drainage on Pressure Injuries
A study testing Experimental in people with Pressure Injuries and MANUEL LENFATIK DRENAJ, run by Rukiye Kokkiz.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Injuries, MANUEL LENFATIK DRENAJ
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Manual Lymphatic Drainage on Pressure Injuries: A Pilot Study Example
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.
- Conditions
- Pressure Injuries, MANUEL LENFATIK DRENAJ
- Being tested
- Experimental, Control
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Experimental |
| comparison group | Active comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rukiye Kokkiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rukiye Kokkiz, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677761
- Sponsor's protocol ID
- Pressure Injury - MLD
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Manual Lymphatic Drainage on Pressure Injuries: A Pilot Study Example
- ClinicalTrials.gov ID
- NCT07677761
- Acronym / sponsor ID
- Pressure Injury - MLD
- Conditions
- Pressure Injuries, MANUEL LENFATIK DRENAJ
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rukiye KokkizUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual lymphatic drainage group | Active comparator | Other: ExperimentalIndividuals 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. |
| comparison group | Active comparator | Other: Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExperimentalIndividuals 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 | Manual lymphatic drainage group |
| ControlStandard 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. | Other | comparison group |
Primary outcome
Effect of manual lymphatic drainage
Time frame: 3 months
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Pressure Injuries and MANUEL LENFATIK DRENAJ, run by Rukiye Kokkiz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact rukiye kökkız, LECTURER (+90 507 140 68 98, rky_kokkiz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of manual lymphatic drainage (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.