Peripheral EdemaSCDNCT07305870
Sequential Compression Device in Distributive Peripheral Edema and Hemodynamic Stability Among Patients in Critical Care Units
A study testing Sequential compression device in people with Peripheral Edema, run by Karbala University at 1 site in Iraq.
Trial summary
Objectives of The Study: 1. Assess the effectiveness of sequential compression device on distributive peripheral edema and hemodynamic stability for patients in critical care units. 2. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peripheral Edema
- What is being tested?
- Sequential compression device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteIraq
- Study dates
- 28 Dec 2025to 20 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who were hospitalized in critical care units.
- Subjects over the age of 18 years.
- Presence of peripheral edema (pitting edema ≥1+ in lower extremities).
- Patients how are hemodynamically stable.
- Patients how are able to tolerate positioning for interventions.
Who cannot join
- Patients with lymphedema.
- Patients with chronic kidney disease.
- patients with presence of deep vein thrombosis, severe peripheral arterial disease, or phlebitis.
- patients with open wounds, ulcers, or skin infections on lower limbs.
- patients with fractures, orthopedic surgery, or joint immobility in lower extremities.
- patients with severe cardiac failure or pulmonary edema.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Sequential Compression Device in Distributive Peripheral Edema and Hemodynamic Stability Among Patients in Critical Care Units
Objectives of The Study:
- Assess the effectiveness of sequential compression device on distributive peripheral edema and hemodynamic stability for patients in critical care units.
- Find out relationships between the effectiveness of sequential compression device, range of motion, and synergic effectiveness of both interventions with patients' demographic characteristics.
Read the detailed description
Globally, approximately (13-20) million people treated in intensive care units (ICUs) each year, where common complications such as edema are due to prolonged immobility and critical illness . Edema refers to accumulation of excess fluid in body tissues, manifesting in multi forms such as cerebral, pulmonary, or ocular edema. Peripheral edema considered one of the most prevalent types, specifically represents to swelling in the limbs. It caused by imbalance between oncotic and hydrostatic pressures, leading to increased capillary permeability and fluid accumulation in the interstitial space(Smith et al., 2024).
A study found that hospital mortality was significantly higher in those presenting with peripheral edema (22.2%) compared with those without (12.6%) among 12,778 critically ill patients. Also, the severity of edema at admission correlated with increased mortality risk.
The prevalence of peripheral lower limb edema among older adults in U.S was 20.0%, 19.4%, 19.0%, 19.0%, and 19.1% in 2000, 2004, 2008, 2012, and 2016, respectively. It was significantly associated with clinical, demographic, and lifestyle factors, including obesity, diabetes, hypertension, pain, low physical activity, mobility limitations, advanced age, female sex, minority race, and low socioeconomic status.
In Japan, the Ministry of Health, Labor, and Welfare reported an increase in the number of patients with severe motion disabilities, particularly among individuals over 60 years old. Similarly, data from the Health and Retirement Study revealed that chronic peripheral edema affects approximately 19% to 20% of older adults, particularly among women, racial minorities, and individuals with limited mobility.
Peripheral edema is a multifactorial and complex condition that affects patients suffering from a various of diseases. Its underlying pathology varies considerably, with common causes including congestive heart failure (CHF), liver disease, vascular conditions such as chronic venous insufficiency, and postoperative surgical complications.
- Conditions
- Peripheral Edema
- Being tested
- Sequential compression device
- Keywords
- Sequential compression device, Peripheral edema, Hemodynamic stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential compression deviceDevice
Sequential Compression Device (SCD) protocol involves a pump linked to calf and thigh braces with individual tubes, applying moderate pressure of approximately 60mmHg through a graduated air chamber in a sequential cycle across four compartments. The inflation lasts for 12 seconds followed by a 48-second deflation, with sessions lasting 2 hours daily for 5 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Sequential Compression Device group | Active comparator | Sequential Compression Device (SCD) participants group involves a pump linked to calf and thigh braces with individual tubes, applying moderate pressure of approximately 60mmHg through a graduated air chamber in a sequential cycle across four compartments. The inflation lasts for 12 seconds followed by a 48-second deflation, with sessions lasting 2 hours daily for 5 consecutive days. Receives: Device: Sequential compression device |
| control group | No intervention | control group will receives standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral edema
Firstly, the edema of lower extremities was measured for all patients in critical care units through pitting edema scale before selecting the participants, then the patients selected for the current study had pitting edema scale >+1. Also, leg circumference had measured by using tape measurement.
Measured: The degree of edema will be measured before applying interventions and after 5 consecutive days if study
Hemodynamic Stability
Hemodynamic parameters were also assessed before interventions. The Hemodynamic parameters that include the heart rate, blood pressure, respiratory rate, urine output and saturation of oxygen was measured by observation of the reading on the monitoring device that was used in critical care units and attached to the patient, the reading was documented by the researcher.
Measured: Hemodynamic parameters will be measured before applying interventions and after 5 consecutive days if study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start28 Dec 2025
- Primary completion15 Mar 2026
- Study completion20 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral EdemaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sequential Compression Device (SCD) protocol involves a pump linked to calf and thigh braces with individual tubes, applying moderate pressure of approximately 60mmHg through a graduated air chamber in a sequential cycle across four compartments. The inflation lasts for 12 seconds followed by a 48-second deflation, with sessions lasting 2 hours daily for 5 consecutive days. In addition control group will receive slandered care which is limps elevation
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karbala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussein Hamza Jawad, Ministry of Health, Iraq
- Investigators
- Hussein H Jawad MGS study principal investigator, Principal investigator, Kerbala health department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305870
- Sponsor's protocol ID
- uok.coN.25.099
- Acronym
- SCD
- Status last verified
- Aug 2026
- First submitted
- 12 Dec 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Sequential Compression Device in Distributive Peripheral Edema and Hemodynamic Stability Among Patients in Critical Care Units
- ClinicalTrials.gov ID
- NCT07305870
- Acronym / sponsor ID
- SCD / uok.coN.25.099
- Conditions
- Peripheral Edema
- Keywords
- Sequential compression device, Peripheral edema, Hemodynamic stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Karbala UniversityUniversity, hospital or other
- Study start
- 28 Dec 2025 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 20 Jul 2026 (actual)
- First posted
- 26 Dec 2025 (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.
Objectives of The Study:
- Assess the effectiveness of sequential compression device on distributive peripheral edema and hemodynamic stability for patients in critical care units.
- Find out relationships between the effectiveness of sequential compression device, range of motion, and synergic effectiveness of both interventions with patients' demographic characteristics.
Detailed description
Globally, approximately (13-20) million people treated in intensive care units (ICUs) each year, where common complications such as edema are due to prolonged immobility and critical illness . Edema refers to accumulation of excess fluid in body tissues, manifesting in multi forms such as cerebral, pulmonary, or ocular edema. Peripheral edema considered one of the most prevalent types, specifically represents to swelling in the limbs. It caused by imbalance between oncotic and hydrostatic pressures, leading to increased capillary permeability and fluid accumulation in the interstitial space(Smith et al., 2024).
A study found that hospital mortality was significantly higher in those presenting with peripheral edema (22.2%) compared with those without (12.6%) among 12,778 critically ill patients. Also, the severity of edema at admission correlated with increased mortality risk.
The prevalence of peripheral lower limb edema among older adults in U.S was 20.0%, 19.4%, 19.0%, 19.0%, and 19.1% in 2000, 2004, 2008, 2012, and 2016, respectively. It was significantly associated with clinical, demographic, and lifestyle factors, including obesity, diabetes, hypertension, pain, low physical activity, mobility limitations, advanced age, female sex, minority race, and low socioeconomic status.
In Japan, the Ministry of Health, Labor, and Welfare reported an increase in the number of patients with severe motion disabilities, particularly among individuals over 60 years old. Similarly, data from the Health and Retirement Study revealed that chronic peripheral edema affects approximately 19% to 20% of older adults, particularly among women, racial minorities, and individuals with limited mobility.
Peripheral edema is a multifactorial and complex condition that affects patients suffering from a various of diseases. Its underlying pathology varies considerably, with common causes including congestive heart failure (CHF), liver disease, vascular conditions such as chronic venous insufficiency, and postoperative surgical complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sequential Compression Device (SCD) protocol involves a pump linked to calf and thigh braces with individual tubes, applying moderate pressure of approximately 60mmHg through a graduated air chamber in a sequential cycle across four compartments. The inflation lasts for 12 seconds followed by a 48-second deflation, with sessions lasting 2 hours daily for 5 consecutive days. In addition control group will receive slandered care which is limps elevation
| Arm | Type | Receives |
|---|---|---|
| Sequential Compression Device group | Active comparator | Device: Sequential compression deviceSequential Compression Device (SCD) participants group involves a pump linked to calf and thigh braces with individual tubes, applying moderate pressure of approximately 60mmHg through a graduated air chamber in a sequential cycle across four compartments. The inflation lasts for 12 seconds followed by a 48-second deflation, with sessions lasting 2 hours daily for 5 consecutive days. |
| control group | No intervention | –control group will receives standard care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients who were hospitalized in critical care units.
- Subjects over the age of 18 years.
- Presence of peripheral edema (pitting edema ≥1+ in lower extremities).
- Patients how are hemodynamically stable.
- Patients how are able to tolerate positioning for interventions.
Key exclusion criteria (6 listed)
- Patients with lymphedema.
- Patients with chronic kidney disease.
- patients with presence of deep vein thrombosis, severe peripheral arterial disease, or phlebitis.
- patients with open wounds, ulcers, or skin infections on lower limbs.
- patients with fractures, orthopedic surgery, or joint immobility in lower extremities.
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 |
|---|---|---|
| Sequential compression deviceSequential Compression Device (SCD) protocol involves a pump linked to calf and thigh braces with individual tubes, applying moderate pressure of approximately 60mmHg through a graduated air chamber in a sequential cycle across four compartments. The inflation lasts for 12 seconds followed by a 48-second deflation, with sessions lasting 2 hours daily for 5 consecutive days. | Device | Sequential Compression Device group |
Primary outcome
Peripheral edema
Time frame: The degree of edema will be measured before applying interventions and after 5 consecutive days if study
Firstly, the edema of lower extremities was measured for all patients in critical care units through pitting edema scale before selecting the participants, then the patients selected for the current study had pitting edema scale >+1. Also, leg circumference had measured by using tape measurement.
Hemodynamic Stability
Time frame: Hemodynamic parameters will be measured before applying interventions and after 5 consecutive days if study
Hemodynamic parameters were also assessed before interventions. The Hemodynamic parameters that include the heart rate, blood pressure, respiratory rate, urine output and saturation of oxygen was measured by observation of the reading on the monitoring device that was used in critical care units and attached to the patient, the reading was documented by the researcher.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Peripheral Edema
Recruiting
The HEARTFELT Study
Heart Failure, Chronic Heart Failure
RecruitingPhase 3
Phase 3, Open-Label Extension Study of AMBTX-01 (Neridronate) for Complex Regional Pain Syndrome Type 1
Complex Regional Pain Syndrome Type I
Active, not recruiting
CI Following VS Removal or Labyrinthectomy
Vestibular Schwannoma, Meniere Disease
RecruitingPhase 3
Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
Complex Regional Pain Syndrome Type I
RecruitingObservational study
Patients With Type 2 Diabetes
Diabetes Mellitus Type 2
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. This study is not recruiting at the moment.
Hussein H Jawad MGS study principal investigator principal investigator
Kerbala health department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sequential compression device in people with Peripheral Edema, run by Karbala University at 1 site in Iraq.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral edema (time frame: The degree of edema will be measured before applying interventions and after 5 consecutive days if study). The study lists 2 primary outcomes in all. 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 5 Aug 2026.