Chronic Venous InsufficiencyNCT03904602
EdemaWear to Reduce Edema in Hospitalized Patients With CVI:
A study testing Edema Wear fuzzy wale compression garment in people with Chronic Venous Insufficiency, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this pilot study is to evaluate the effectiveness of EdemaWear® fuzzy wale longitudinal compression stockings on reducing lower extremity edema in hospitalized adult patients with a history of CVI who are at high risk of consequent venous leg ulcers (VLU) and patient experience with continuously wearing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Insufficiency
- What is being tested?
- Edema Wear fuzzy wale compression garment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2019to 15 Sep 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- history of CVI (Clinical classification 1-5), with > 2+ edema of the lower legs,
- > 2+ peripheral pulses (popliteal, dorsalis pedis [DP], and posterior tibial [PT]) or audible biphasic / triphasic Doppler signal, if pulses not palpable.
Who cannot join
- open venous stasis ulcer(s) or other wounds on lower legs
- lymphedema or risk factors for lymphedema
- acute heart failure with active management
- known deep vein thrombosis (DVT) with subtherapeutic anticoagulation
- peripheral arterial disease (PAD) with reduced / absent pulses
- known or suspected inferior vena caval (IVC) compression
- circumference of lower leg < 45 cm or > 115 cm (size limits of small and extra-large EdemaWear®)
- severely altered mental status or lacking capacity to consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: EdemaWear to Reduce Edema in Hospitalized Patients With Chronic Venous Insufficiency: A Pilot Study
The purpose of this pilot study is to evaluate the effectiveness of EdemaWear® fuzzy wale longitudinal compression stockings on reducing lower extremity edema in hospitalized adult patients with a history of CVI who are at high risk of consequent venous leg ulcers (VLU) and patient experience with continuously wearing Edema Wear for up to five days
Read the detailed description
Hospitalized patients with chronic venous insufficiency (CVI) are at high risk of venous leg ulcers (VLU) due to lower leg edema and skin changes. Since VLU are associated with prolonged morbidity and appreciable financial burden to the patient and society, prevention of VLU by reduction of lower leg edema is paramount. Although the mainstay of VLU prevention is compression, there is a gap in the acute care toolbox to manage the symptom of CVI edema. Currently, ACE bandages are the single most common 'compression wraps' stocked on inpatient units. The disadvantages of ace wraps, which are long-stretch bandages, are two-fold: 1) lower working pressure impeding venous return to the heart, and 2) higher resting pressure that may cause a tourniquet effect and consequent tissue ischemia. A newer moderately-priced mild compression product (15-20 mmHg), EdemaWear® longitudinal elastic compression stockinet, offers an alternative for hospitalized patients. There is limited evidence about the effectiveness of EdemaWear® (that is, modest reduction of lower leg edema) derived from one case series and two comparative evaluations involving only patients in out-patient clinics. This pilot study will expand the evidence related to the effectiveness of EdemaWear® in reducing lower leg edema to include hospitalized patients with CVI. .
The proposed pilot interventional study which involves a single-group repeated measures design with mixed methods has three aims:
- evaluate the effectiveness of EdemaWear fuzzy wale elastic compression stockinet in reducing lower extremity edema in hospitalized adult patients with chronic venous insufficiency as measured by the difference in the volume of each lower extremity from Day 1 and Day 5 of data collection or the day of discharge if it occurs in less than five days
- determine through interviews the experience of patients continuously wearing EdemaWear compression garment for up to five days or hospital discharge if it occurs in less than five days
- qualitatively describe nurses' perceptions of their patients experience with continuously wearing EdemaWear compression garment for up to five days or hospital discharge if it occurs in less than five days
The procedure:
- Initial data collection related to demographic variables (age, gender, race, ethnic background), primary diagnosis, comorbid conditions (Charlson Comorbidity Index), CEAP classification of chronic venous disease, medication / treatment regimen, degree of lower extremity edema, volume of lower leg peripheral pulses, ankle-brachial indexes
- Daily data collection related to changes in health status and treatment
- Daily measurement of the girth of both lower extremities at 10 cm intervals from mid-foot, up the legs, to just below the knees.
- Daily interviews of patient and nursing staff related to experience of continuously wearing EdemaWear for up to five days or hospital discharge if it occurs in less than five days
Data analysis:
- Descriptive statistics will be performed on demographic and physiological variables, including number / percent for nominal variables and mean (+SD) for continuous variables. Data will be analyzed to decide whether they meet the assumptions of the planned analyses. Repeated measures ANOVA will be used to determine whether there are significant differences in the volume of the lower legs treated with EdemaWear® across the five time periods. The alpha level will be set at p < .05.
Qualitative data from daily interviews of patients and nursing staff will be analyzed by
- the PI and Co-Is of this study. Content analysis will be used to analyze the data. The unit of analysis will be phrases or sentences contained in responses to questions in the Interview Guides. Content Analysis is a qualitative research method that is used to isolate and interpret themes, issues, and repeated patterns. They refine understanding as new insights about the data emerge. The strategies for analysis outlined by Downe - Wamboldt will be followed.
- Conditions
- Chronic Venous Insufficiency
- Being tested
- Edema Wear fuzzy wale compression garment
- Keywords
- Chronic Venous Insufficiency, CVI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edema Wear fuzzy wale compression garmentDevice
net-like compression structure of Lycra spandex elastic yarn with longitudinal fuzzy wales (similar to corduroy fabric)
| Study group | Role | What they receive |
|---|---|---|
| Edema Wear | Experimental | Edema Wear fuzzy wale compression garment worn on lower extremities continuously for 5 days or until discharge if less than 5 days. Receives: Device: Edema Wear fuzzy wale compression garment |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in lower leg volume
Difference between volume of lower leg / foot between Day 1 and Day 5 (or day of hospital discharge if less than 5 days)
Measured: up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start19 Aug 2019
- Primary completion15 Sep 2019
- Study completion15 Sep 2019
Why it stopped: Patients experienced translocation of edema from lower extremities to trunk heightening concern about triggering congestive heart failure in frail elders.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Chronic Venous InsufficiencyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virginia Capasso, Massachusetts General Hospital
- Investigators
- Virginia Capasso, PhD, APRN, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904602
- Sponsor's protocol ID
- 2018 JIE
- Status last verified
- Mar 2023
- First submitted
- 3 Apr 2019
- Last updated
- 23 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lal BK. Venous ulcers of the lower extremity: Definition, epidemiology, and economic and social burdens. Semin Vasc Surg. 2015 Mar;28(1):3-5. doi: 10.1053/j.semvascsurg.2015.05.002. Epub 2015 May 8.
PubMed 26358303O'Donnell TF Jr, Passman MA, Marston WA, Ennis WJ, Dalsing M, Kistner RL, Lurie F, Henke PK, Gloviczki ML, Eklof BG, Stoughton J, Raju S, Shortell CK, Raffetto JD, Partsch H, Pounds LC, Cummings ME, Gillespie DL, McLafferty RB, Murad MH, Wakefield TW, Gloviczki P; Society for Vascular Surgery; American Venous Forum. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery (R) and the American Venous Forum. J Vasc Surg. 2014 Aug;60(2 Suppl):3S-59S. doi: 10.1016/j.jvs.2014.04.049. Epub 2014 Jun 25. No abstract available.
PubMed 24974070Eberhardt RT, Raffetto JD. Chronic venous insufficiency. Circulation. 2014 Jul 22;130(4):333-46. doi: 10.1161/CIRCULATIONAHA.113.006898. No abstract available.
PubMed 25047584Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
PubMed 3558716Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.
PubMed 16000093Brodovicz KG, McNaughton K, Uemura N, Meininger G, Girman CJ, Yale SH. Reliability and feasibility of methods to quantitatively assess peripheral edema. Clin Med Res. 2009 Jun;7(1-2):21-31. doi: 10.3121/cmr.2009.819. Epub 2009 Feb 26.
PubMed 19251582Gogalniceanu P, Lancaster RT, Patel VI. Clinical Assessment of Peripheral Arterial Disease of the Lower Limbs. N Engl J Med. 2018 May 3;378(18):e24. doi: 10.1056/NEJMvcm1406358. No abstract available.
PubMed 29719182Bailey MA, Griffin KJ, Scott DJ. Clinical assessment of patients with peripheral arterial disease. Semin Intervent Radiol. 2014 Dec;31(4):292-9. doi: 10.1055/s-0034-1393964.
PubMed 25435653Aboyans V, Criqui MH, Abraham P, Allison MA, Creager MA, Diehm C, Fowkes FG, Hiatt WR, Jonsson B, Lacroix P, Marin B, McDermott MM, Norgren L, Pande RL, Preux PM, Stoffers HE, Treat-Jacobson D; American Heart Association Council on Peripheral Vascular Disease; Council on Epidemiology and Prevention; Council on Clinical Cardiology; Council on Cardiovascular Nursing; Council on Cardiovascular Radiology and Intervention, and Council on Cardiovascular Surgery and Anesthesia. Measurement and interpretation of the ankle-brachial index: a scientific statement from the American Heart Association. Circulation. 2012 Dec 11;126(24):2890-909. doi: 10.1161/CIR.0b013e318276fbcb. Epub 2012 Nov 16. No abstract available.
PubMed 23159553Sibley RC 3rd, Reis SP, MacFarlane JJ, Reddick MA, Kalva SP, Sutphin PD. Noninvasive Physiologic Vascular Studies: A Guide to Diagnosing Peripheral Arterial Disease. Radiographics. 2017 Jan-Feb;37(1):346-357. doi: 10.1148/rg.2017160044. Epub 2016 Sep 30.
PubMed 27689831Casley-Smith JR. Measuring and representing peripheral oedema and its alterations. Lymphology. 1994 Jun;27(2):56-70.
PubMed 8078362Latchford S, Casley-Smith JR. Estimating limb volumes and alterations in peripheral edema from circumferences measured at different intervals. Lymphology. 1997 Dec;30(4):161-4. No abstract available.
PubMed 9476247Downe-Wamboldt B. Content analysis: method, applications, and issues. Health Care Women Int. 1992 Jul-Sep;13(3):313-21. doi: 10.1080/07399339209516006.
PubMed 1399871
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EdemaWear to Reduce Edema in Hospitalized Patients With Chronic Venous Insufficiency: A Pilot Study
- ClinicalTrials.gov ID
- NCT03904602
- Acronym / sponsor ID
- 2018 JIE
- Conditions
- Chronic Venous Insufficiency
- Keywords
- Chronic Venous Insufficiency, CVI
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patients experienced translocation of edema from lower extremities to trunk heightening concern about triggering congestive heart failure in frail elders.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 5 Apr 2019 (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.
The purpose of this pilot study is to evaluate the effectiveness of EdemaWear® fuzzy wale longitudinal compression stockings on reducing lower extremity edema in hospitalized adult patients with a history of CVI who are at high risk of consequent venous leg ulcers (VLU) and patient experience with continuously wearing Edema Wear for up to five days
Detailed description
Hospitalized patients with chronic venous insufficiency (CVI) are at high risk of venous leg ulcers (VLU) due to lower leg edema and skin changes. Since VLU are associated with prolonged morbidity and appreciable financial burden to the patient and society, prevention of VLU by reduction of lower leg edema is paramount. Although the mainstay of VLU prevention is compression, there is a gap in the acute care toolbox to manage the symptom of CVI edema. Currently, ACE bandages are the single most common 'compression wraps' stocked on inpatient units. The disadvantages of ace wraps, which are long-stretch bandages, are two-fold: 1) lower working pressure impeding venous return to the heart, and 2) higher resting pressure that may cause a tourniquet effect and consequent tissue ischemia. A newer moderately-priced mild compression product (15-20 mmHg), EdemaWear® longitudinal elastic compression stockinet, offers an alternative for hospitalized patients. There is limited evidence about the effectiveness of EdemaWear® (that is, modest reduction of lower leg edema) derived from one case series and two comparative evaluations involving only patients in out-patient clinics. This pilot study will expand the evidence related to the effectiveness of EdemaWear® in reducing lower leg edema to include hospitalized patients with CVI. .
The proposed pilot interventional study which involves a single-group repeated measures design with mixed methods has three aims:
- evaluate the effectiveness of EdemaWear fuzzy wale elastic compression stockinet in reducing lower extremity edema in hospitalized adult patients with chronic venous insufficiency as measured by the difference in the volume of each lower extremity from Day 1 and Day 5 of data collection or the day of discharge if it occurs in less than five days
- determine through interviews the experience of patients continuously wearing EdemaWear compression garment for up to five days or hospital discharge if it occurs in less than five days
- qualitatively describe nurses' perceptions of their patients experience with continuously wearing EdemaWear compression garment for up to five days or hospital discharge if it occurs in less than five days
The procedure:
- Initial data collection related to demographic variables (age, gender, race, ethnic background), primary diagnosis, comorbid conditions (Charlson Comorbidity Index), CEAP classification of chronic venous disease, medication / treatment regimen, degree of lower extremity edema, volume of lower leg peripheral pulses, ankle-brachial indexes
- Daily data collection related to changes in health status and treatment
- Daily measurement of the girth of both lower extremities at 10 cm intervals from mid-foot, up the legs, to just below the knees.
- Daily interviews of patient and nursing staff related to experience of continuously wearing EdemaWear for up to five days or hospital discharge if it occurs in less than five days
Data analysis:
- Descriptive statistics will be performed on demographic and physiological variables, including number / percent for nominal variables and mean (+SD) for continuous variables. Data will be analyzed to decide whether they meet the assumptions of the planned analyses. Repeated measures ANOVA will be used to determine whether there are significant differences in the volume of the lower legs treated with EdemaWear® across the five time periods. The alpha level will be set at p < .05.
Qualitative data from daily interviews of patients and nursing staff will be analyzed by
- the PI and Co-Is of this study. Content analysis will be used to analyze the data. The unit of analysis will be phrases or sentences contained in responses to questions in the Interview Guides. Content Analysis is a qualitative research method that is used to isolate and interpret themes, issues, and repeated patterns. They refine understanding as new insights about the data emerge. The strategies for analysis outlined by Downe - Wamboldt will be followed.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Edema Wear | Experimental | Device: Edema Wear fuzzy wale compression garmentEdema Wear fuzzy wale compression garment worn on lower extremities continuously for 5 days or until discharge if less than 5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- history of CVI (Clinical classification 1-5), with > 2+ edema of the lower legs,
- > 2+ peripheral pulses (popliteal, dorsalis pedis [DP], and posterior tibial [PT]) or audible biphasic / triphasic Doppler signal, if pulses not palpable.
Key exclusion criteria (8 listed)
- open venous stasis ulcer(s) or other wounds on lower legs
- lymphedema or risk factors for lymphedema
- acute heart failure with active management
- known deep vein thrombosis (DVT) with subtherapeutic anticoagulation
- peripheral arterial disease (PAD) with reduced / absent pulses
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 |
|---|---|---|
| Edema Wear fuzzy wale compression garmentnet-like compression structure of Lycra spandex elastic yarn with longitudinal fuzzy wales (similar to corduroy fabric) | Device | Edema Wear |
Primary outcome
change in lower leg volume
Time frame: up to 5 days
Difference between volume of lower leg / foot between Day 1 and Day 5 (or day of hospital discharge if less than 5 days)
Results and safety
The study was stopped early (reason given: Patients experienced translocation of edema from lower extremities to trunk heightening concern about triggering congestive heart failure in frail elders.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Background: PubMed 26358303Lal BK. Venous ulcers of the lower extremity: Definition, epidemiology, and economic and social burdens. Semin Vasc Surg. 2015 Mar;28(1):3-5. doi: 10.1053/j.semvascsurg.2015.05.002. Epub 2015 May 8.
- Background: PubMed 24974070O'Donnell TF Jr, Passman MA, Marston WA, Ennis WJ, Dalsing M, Kistner RL, Lurie F, Henke PK, Gloviczki ML, Eklof BG, Stoughton J, Raju S, Shortell CK, Raffetto JD, Partsch H, Pounds LC, Cummings ME, Gillespie DL, McLafferty RB, Murad MH, Wakefield TW, Gloviczki P; Society for Vascular Surgery; American Venous Forum. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery (R) and the American Venous Forum. J Vasc Surg. 2014 Aug;60(2 Suppl):3S-59S. doi: 10.1016/j.jvs.2014.04.049. Epub 2014 Jun 25. No abstract available.
- Background: PubMed 25047584Eberhardt RT, Raffetto JD. Chronic venous insufficiency. Circulation. 2014 Jul 22;130(4):333-46. doi: 10.1161/CIRCULATIONAHA.113.006898. No abstract available.
- Background: PubMed 3558716Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
- Background: PubMed 16000093Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.
- Background: PubMed 19251582Brodovicz KG, McNaughton K, Uemura N, Meininger G, Girman CJ, Yale SH. Reliability and feasibility of methods to quantitatively assess peripheral edema. Clin Med Res. 2009 Jun;7(1-2):21-31. doi: 10.3121/cmr.2009.819. Epub 2009 Feb 26.
- Background: PubMed 29719182Gogalniceanu P, Lancaster RT, Patel VI. Clinical Assessment of Peripheral Arterial Disease of the Lower Limbs. N Engl J Med. 2018 May 3;378(18):e24. doi: 10.1056/NEJMvcm1406358. No abstract available.
- Background: PubMed 25435653Bailey MA, Griffin KJ, Scott DJ. Clinical assessment of patients with peripheral arterial disease. Semin Intervent Radiol. 2014 Dec;31(4):292-9. doi: 10.1055/s-0034-1393964.
- Background: PubMed 23159553Aboyans V, Criqui MH, Abraham P, Allison MA, Creager MA, Diehm C, Fowkes FG, Hiatt WR, Jonsson B, Lacroix P, Marin B, McDermott MM, Norgren L, Pande RL, Preux PM, Stoffers HE, Treat-Jacobson D; American Heart Association Council on Peripheral Vascular Disease; Council on Epidemiology and Prevention; Council on Clinical Cardiology; Council on Cardiovascular Nursing; Council on Cardiovascular Radiology and Intervention, and Council on Cardiovascular Surgery and Anesthesia. Measurement and interpretation of the ankle-brachial index: a scientific statement from the American Heart Association. Circulation. 2012 Dec 11;126(24):2890-909. doi: 10.1161/CIR.0b013e318276fbcb. Epub 2012 Nov 16. No abstract available.
- Background: PubMed 27689831Sibley RC 3rd, Reis SP, MacFarlane JJ, Reddick MA, Kalva SP, Sutphin PD. Noninvasive Physiologic Vascular Studies: A Guide to Diagnosing Peripheral Arterial Disease. Radiographics. 2017 Jan-Feb;37(1):346-357. doi: 10.1148/rg.2017160044. Epub 2016 Sep 30.
- Background: PubMed 8078362Casley-Smith JR. Measuring and representing peripheral oedema and its alterations. Lymphology. 1994 Jun;27(2):56-70.
- Background: PubMed 9476247Latchford S, Casley-Smith JR. Estimating limb volumes and alterations in peripheral edema from circumferences measured at different intervals. Lymphology. 1997 Dec;30(4):161-4. No abstract available.
- Bjork R. The long and short of it: Understanding compression bandaging. Wound Care Advisor. 2013; 2(6).Link provided by the sponsor.
- EdemaWear® New Compression Textile.Link provided by the sponsor.
- numeric-pain-rating-scaleLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Virginia Capasso, PhD, APRN principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Edema Wear fuzzy wale compression garment in people with Chronic Venous Insufficiency, run by Massachusetts General Hospital at 1 site in United States.
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 2 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: stopped early, as of the sponsor's last update on 23 Mar 2023. 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 United States. 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 was stopped early (reason given: Patients experienced translocation of edema from lower extremities to trunk heightening concern about triggering congestive heart failure in frail elders.). Results are not available in the source record.
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?
change in lower leg volume (time frame: up to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03904602, which also lists 13 linked publications.
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 23 Mar 2023.