LymphedemaACWNCT07109674
Adjustable Compression Wraps (ACW) in Lymphedema
A study testing adjustable compression device (type circaid® reduction kit, Medi-Bayreuth) and Comparison of inelastic compression efficiency in people with Lymphedema and Lymphedema Arm, run by University School of Physical Education, Krakow, Poland at 1 site in Poland.
Trial summary
Compression therapy based on multilayer compression bandaging and com pression garment use remains the most efficient component of complex physical therapy (CPT) in lymphedema treatment. The proper self-application of compression bandages is generally considered as problematic. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphedema, Lymphedema Arm, Breast Cancer
- What is being tested?
- adjustable compression device (type circaid® reduction kit, Medi-Bayreuth) and Comparison of inelastic compression efficiency
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 sitePoland
- Study dates
- 3 Jan 2024to 30 Mar 2025
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stage-II of lymphedema (according to ISL)
- ≥20% excess limb volumes
- positive pitting skin sign
- absent signs of active cancer
- absent of venous thrombosis
Who cannot join
- active cancer during oncological treatment
- using compression
- stage-I of lymphedema (according to ISL)
- < 20 % excess limb volumes
Trial locations and contacts
1 site in 1 country.
Poland1 site
University School of Physical Education
Krakow, Małopolska, 31-571
About this study
Official title: Inelastic Compression With a High Stiffness Index in Breast Cancer-related Lymphedema: A Prospective Case - Control Study
Compression therapy based on multilayer compression bandaging and com pression garment use remains the most efficient component of complex physical therapy (CPT) in lymphedema treatment. The proper self-application of compression bandages is generally considered as problematic. Adjustable compression wraps (ACW) have been proposed as an alternative to the commonly used short-stretch bandages for lymphedema. These systems allow easy application and removal for patients. They have been tested in patients with vascular disorders of the lower limbs and can be considered in breast cancer survivors with upper-limb lymphedema.
The objective of this study was to compare the effectiveness, physical functioning and comfort of 2 types inelastic compression: adjustable compression wrap (reduction) and multi-layer compression bandaging at the intensive phase of treatment in advanced upper limb lymphedema among breast cancer survivors.
Read the detailed description
55 women after breast cancer treatment admitted to the Lymphedema Clinic and patients fulfilled the admission criteria - stage-II (according to ISL) lymphedema, ≥20% excess limb volumes, positive pitting skin sign, and absent signs of active cancer, venous thrombosis or previous compression were assigned into the experimental group with the adjustable compression wrap redcution kit, ACW - Group or the control with compression bandaging, CB-Group.
In the ACW reduction group, adjustable compression garments (typ circaid® reduction kit, Medi-Bayreuth) was also fitted based on individual limb measurements with ability to reduce size of garment as the limb volume decreases. The kit included a card with a color scale that allowed users to achieve the appropriate pressure of 20-30 mmHg. The next day, in order to refresh and moisturize the skin, these products were removed for a short period prior to the next therapeutic session. They were used for 24 hours.
In the CB group, multi-layer bandaging of the limb was performed using short stretch bandages with pads (Rosidal K, Lohmann \& Raucher). At the beginning of bandaging, a cotton tube stockinet was placed on the arm, a layer of gauze was applied to the fingers and hand. A layer of foam padding (Lymphset: Lohmann \& Raucher) was placed on the hand and wrapped around the arm. Three bandages of different sizes (8, 10, 12 cm in width) were placed around the limb with the first starting at the hand, the second at the wrist and the third beginning below the elbow. Sub-bandage pressure was measured via the Kikushime device (Kikgel, Ujazd Poland) on the dorsal part of the forearm, as well as on the arm, to ensure a pressure value within the range of 20-30 mmHg, comparable to pressure used in the compression system among the ACW Group. Bandages were removed for a short time before the therapeutic session the next day, as in the ACW-Group, and put on the next day. The exercise program including aerobic exercises of the upper limbs combined with deep breathing was performed in adjustable compression wraps or bandaging for 15 minutes in 1 session per day.
Measurements, including physical functioning, limb volumes and disease-related symptoms, were performed before the intervention and after treatment in both groups. Circumferential upper limb measurements were taken with the arm abducted at 30°, starting at the level of the ulnar styloid, every 4 cm proximal to this point along both limbs. Calculation of limb segment volumes was carried out using a simplified frustum formula (summed truncated cone). The excess volume was the difference between the affected and unaffected limbs expressed in litres. The percentage reduction of the excess volume was obtained as follows: (excess volume before treatment - excess volume after treatment) x 100/excess volume before treatment.
Patients rated their physical functioning, disease-related symptoms, compression comfort and complications of compression on a numerical rating scale (NRS) based on the International Compression Club (ICC) Questionnaire - Part for Patients. Firstly, the patients assessed their physical functioning (sum of ability to move wrist, elbow, shoulder; use a spoon; carry out work; complete household chores; practice sports' carry out leisure activities; social activities, on the Number Rating Scale (NRS; 0 = not able at all, 10 = completely able) and disease-related symptoms (sum of pain; loss of muscle strength; heaviness; swelling; tight skin; tingling; leakage; NRS: 0 = no complaints, 10 = the highest intensity), first without the tested compression and continued after 1 and 2 weeks using the compression device. Complications of compression related to skin irritation; tender spots; skin damage; itching; warmth; throbbing; cramps; cutting in; slippage; local swelling; bulky feeling; too tight feeling (NRS: 0 = not present at all, 10 = very obviously present, sum of points) were assessed after 1 and 2 weeks in both groups. Compression comfort including: easy donning; easy doffing; feeling immediately after donning; feeling during daytime; putting on clothes on compression; feeling at night; the appearance of the garment (NRS: 0 = not able at all, 10 = completely able, sum of points) was evaluated after the first and second weeks in both groups.
Treatment in both groups lasted 10 days (2 weeks, Monday to Friday). In the first week, all patients were treated by 2 experienced physiotherapists and educated in applying adjustable compression wraps (ACW reduction group) or self-bandaging (CB group). During the 2nd week, the use of ACW and CB was continued by the patients themselves at home. Patients were asked to maintain the adjustable compression wraps or compression bandaging even during the weekend (Saturday and Sunday).
- Conditions
- Lymphedema, Lymphedema Arm, Breast Cancer
- Being tested
- adjustable compression device (type circaid® reduction kit, Medi-Bayreuth), Comparison of inelastic compression efficiency
- Keywords
- breast cancer survivors, compression therapy, adjustable compression wrap, compression bandaging
- Medical subject headings
- Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjustable compression device (type circaid® reduction kit, Medi-Bayreuth)Device
Also called compression therapy
inelastic compression during intensive phase of physical therapy
Comparison of inelastic compression efficiencyDevice
The effect of compression on volume reduction, physical functioning, disease-related symptoms and comfort
| Study group | Role | What they receive |
|---|---|---|
| Adjustable compression wrap-reduction kit | Experimental | The objective of this study was to compare the effectiveness on volume reduction, physical functioning and comfort of inelastic compression: adjustable compression wrap (reduction) at the intensive phase of treatment in advanced upper limb lymphedema among breast cancer survivors Receives: Device: adjustable compression device (type circaid® reduction kit, Medi-Bayreuth) |
| Compression bandaging | Active comparator | text Receives: Device: Comparison of inelastic compression efficiency |
What is being measured
The primary outcome is the main question the study is designed to answer.
The assessment of limb volume
Measurements including limb volumes were performed before the intervention, and after treatment in both groups. Circumferential upper limb measurements were taken with the arm abducted at 30°, starting at the level of the ulnar styloid, every 4 cm proximal to this point along both limbs. Calculation of limb segment volumes was carried out using a simplified frustum formula (summed truncated cone). The excess volume was the difference between the affected and unaffected limbs expressed in litres. The percentage reduction of the excess volume was obtained as follows: (excess volume before treatment - excess volume after treatment) x 100/excess volume before treatment.
Measured: 14 months
The assessment of physical functioning
Patients rated their physical functioning of the affected limb on a numerical rating scale (NRS) based on the International Compression Club (ICC) Questionnaire - Part for Patients. The patients assessed their physical functioning (sum of ability to move wrist, elbow, shoulder; use a spoon; carry out work; complete household chores; practice sports' carry out leisure activities; social activities, on the Number Rating Scale (NRS; 0 = not able at all, 10 = completely able) before and after treatment in both groups.
Measured: 14 months
The assessment of disease - related symptoms
Patients rated their disease-related symptoms based on the International Compression Club (ICC) Questionnaire - Part for Patients on the Number Rating (sum of pain; loss of muscle strength; heaviness; swelling; tight skin; tingling; leakage; NRS: 0 = no complaints, 10 = the highest intensity) before the intervention and after treatment in both groups.
Measured: 14 months
The assessment of compression comfort
Patients rated their comfort and complications related to compression on a numerical rating scale (NRS) based on the International Compression Club (ICC) Questionnaire - Part for Patients. Complications of compression related to skin irritation; tender spots; skin damage; itching; warmth; throbbing; cramps; cutting in; slippage; local swelling; bulky feeling; too tight feeling (NRS: 0 = not present at all, 10 = very obviously present, sum of points) were assessed after treatment in both groups. Compression comfort including: easy donning; easy doffing; feeling immediately after donning; feeling during daytime; putting on clothes on compression; feeling at night; the appearance of the garment (NRS: 0 = not able at all, 10 = completely able, sum of points) was evaluated after treatment in both groups.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start3 Jan 2024
- Primary completion1 Feb 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LymphedemaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison the physiotherapeutical intervention in breast cancer surivors
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University School of Physical Education, Krakow, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109674
- Sponsor's protocol ID
- 345/BS/IRK/2024
- Acronym
- ACW
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: * limb volume reduction * physical functioning * disease- related symptoms * comfort in compression
Publications
Pujol-Blaya V, Salinas-Huertas S, Catasus ML, Pascual T, Belmonte R. Effectiveness of a precast adjustable compression system compared to multilayered compression bandages in the treatment of breast cancer-related lymphoedema: a randomized, single-blind clinical trial. Clin Rehabil. 2019 Apr;33(4):631-641. doi: 10.1177/0269215518821785. Epub 2019 Jan 4.
PubMed 30607986Ochalek K, Kurpiewska J, Gradalski T. Adjustable Compression Wraps (ACW) vs. Compression Bandaging (CB) in the Acute Phase of Breast Cancer-Related Arm Lymphedema Management-A Prospective Randomized Study. Biology (Basel). 2023 Mar 31;12(4):534. doi: 10.3390/biology12040534.
PubMed 37106735
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inelastic Compression With a High Stiffness Index in Breast Cancer-related Lymphedema: A Prospective Case - Control Study
- ClinicalTrials.gov ID
- NCT07109674
- Acronym / sponsor ID
- ACW / 345/BS/IRK/2024
- Conditions
- Lymphedema, Lymphedema Arm, Breast Cancer
- Keywords
- breast cancer survivors, compression therapy, adjustable compression wrap, compression bandaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University School of Physical Education, Krakow, PolandUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 7 Aug 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.
Compression therapy based on multilayer compression bandaging and com pression garment use remains the most efficient component of complex physical therapy (CPT) in lymphedema treatment. The proper self-application of compression bandages is generally considered as problematic. Adjustable compression wraps (ACW) have been proposed as an alternative to the commonly used short-stretch bandages for lymphedema. These systems allow easy application and removal for patients. They have been tested in patients with vascular disorders of the lower limbs and can be considered in breast cancer survivors with upper-limb lymphedema.
The objective of this study was to compare the effectiveness, physical functioning and comfort of 2 types inelastic compression: adjustable compression wrap (reduction) and multi-layer compression bandaging at the intensive phase of treatment in advanced upper limb lymphedema among breast cancer survivors.
Detailed description
55 women after breast cancer treatment admitted to the Lymphedema Clinic and patients fulfilled the admission criteria - stage-II (according to ISL) lymphedema, ≥20% excess limb volumes, positive pitting skin sign, and absent signs of active cancer, venous thrombosis or previous compression were assigned into the experimental group with the adjustable compression wrap redcution kit, ACW - Group or the control with compression bandaging, CB-Group.
In the ACW reduction group, adjustable compression garments (typ circaid® reduction kit, Medi-Bayreuth) was also fitted based on individual limb measurements with ability to reduce size of garment as the limb volume decreases. The kit included a card with a color scale that allowed users to achieve the appropriate pressure of 20-30 mmHg. The next day, in order to refresh and moisturize the skin, these products were removed for a short period prior to the next therapeutic session. They were used for 24 hours.
In the CB group, multi-layer bandaging of the limb was performed using short stretch bandages with pads (Rosidal K, Lohmann \& Raucher). At the beginning of bandaging, a cotton tube stockinet was placed on the arm, a layer of gauze was applied to the fingers and hand. A layer of foam padding (Lymphset: Lohmann \& Raucher) was placed on the hand and wrapped around the arm. Three bandages of different sizes (8, 10, 12 cm in width) were placed around the limb with the first starting at the hand, the second at the wrist and the third beginning below the elbow. Sub-bandage pressure was measured via the Kikushime device (Kikgel, Ujazd Poland) on the dorsal part of the forearm, as well as on the arm, to ensure a pressure value within the range of 20-30 mmHg, comparable to pressure used in the compression system among the ACW Group. Bandages were removed for a short time before the therapeutic session the next day, as in the ACW-Group, and put on the next day. The exercise program including aerobic exercises of the upper limbs combined with deep breathing was performed in adjustable compression wraps or bandaging for 15 minutes in 1 session per day.
Measurements, including physical functioning, limb volumes and disease-related symptoms, were performed before the intervention and after treatment in both groups. Circumferential upper limb measurements were taken with the arm abducted at 30°, starting at the level of the ulnar styloid, every 4 cm proximal to this point along both limbs. Calculation of limb segment volumes was carried out using a simplified frustum formula (summed truncated cone). The excess volume was the difference between the affected and unaffected limbs expressed in litres. The percentage reduction of the excess volume was obtained as follows: (excess volume before treatment - excess volume after treatment) x 100/excess volume before treatment.
Patients rated their physical functioning, disease-related symptoms, compression comfort and complications of compression on a numerical rating scale (NRS) based on the International Compression Club (ICC) Questionnaire - Part for Patients. Firstly, the patients assessed their physical functioning (sum of ability to move wrist, elbow, shoulder; use a spoon; carry out work; complete household chores; practice sports' carry out leisure activities; social activities, on the Number Rating Scale (NRS; 0 = not able at all, 10 = completely able) and disease-related symptoms (sum of pain; loss of muscle strength; heaviness; swelling; tight skin; tingling; leakage; NRS: 0 = no complaints, 10 = the highest intensity), first without the tested compression and continued after 1 and 2 weeks using the compression device. Complications of compression related to skin irritation; tender spots; skin damage; itching; warmth; throbbing; cramps; cutting in; slippage; local swelling; bulky feeling; too tight feeling (NRS: 0 = not present at all, 10 = very obviously present, sum of points) were assessed after 1 and 2 weeks in both groups. Compression comfort including: easy donning; easy doffing; feeling immediately after donning; feeling during daytime; putting on clothes on compression; feeling at night; the appearance of the garment (NRS: 0 = not able at all, 10 = completely able, sum of points) was evaluated after the first and second weeks in both groups.
Treatment in both groups lasted 10 days (2 weeks, Monday to Friday). In the first week, all patients were treated by 2 experienced physiotherapists and educated in applying adjustable compression wraps (ACW reduction group) or self-bandaging (CB group). During the 2nd week, the use of ACW and CB was continued by the patients themselves at home. Patients were asked to maintain the adjustable compression wraps or compression bandaging even during the weekend (Saturday and Sunday).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison the physiotherapeutical intervention in breast cancer surivors
| Arm | Type | Receives |
|---|---|---|
| Adjustable compression wrap-reduction kit | Experimental | Device: adjustable compression device (type circaid® reduction kit, Medi-Bayreuth)The objective of this study was to compare the effectiveness on volume reduction, physical functioning and comfort of inelastic compression: adjustable compression wrap (reduction) at the intensive phase of treatment in advanced upper limb lymphedema among breast cancer survivors |
| Compression bandaging | Active comparator | Device: Comparison of inelastic compression efficiencytext |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- stage-II of lymphedema (according to ISL)
- ≥20% excess limb volumes
- positive pitting skin sign
- absent signs of active cancer
- absent of venous thrombosis
Key exclusion criteria (4 listed)
- active cancer during oncological treatment
- using compression
- stage-I of lymphedema (according to ISL)
- < 20 % excess limb volumes
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 |
|---|---|---|
| adjustable compression device (type circaid® reduction kit, Medi-Bayreuth)Also: compression therapyinelastic compression during intensive phase of physical therapy | Device | Adjustable compression wrap-reduction kit |
| Comparison of inelastic compression efficiencyThe effect of compression on volume reduction, physical functioning, disease-related symptoms and comfort | Device | Compression bandaging |
Primary outcome
The assessment of limb volume
Time frame: 14 months
Measurements including limb volumes were performed before the intervention, and after treatment in both groups. Circumferential upper limb measurements were taken with the arm abducted at 30°, starting at the level of the ulnar styloid, every 4 cm proximal to this point along both limbs. Calculation of limb segment volumes was carried out using a simplified frustum formula (summed truncated cone). The excess volume was the difference between the affected and unaffected limbs expressed in litres. The percentage reduction of the excess volume was obtained as follows: (excess volume before treatment - excess volume after treatment) x 100/excess volume before treatment.
The assessment of physical functioning
Time frame: 14 months
Patients rated their physical functioning of the affected limb on a numerical rating scale (NRS) based on the International Compression Club (ICC) Questionnaire - Part for Patients. The patients assessed their physical functioning (sum of ability to move wrist, elbow, shoulder; use a spoon; carry out work; complete household chores; practice sports' carry out leisure activities; social activities, on the Number Rating Scale (NRS; 0 = not able at all, 10 = completely able) before and after treatment in both groups.
The assessment of disease - related symptoms
Time frame: 14 months
Patients rated their disease-related symptoms based on the International Compression Club (ICC) Questionnaire - Part for Patients on the Number Rating (sum of pain; loss of muscle strength; heaviness; swelling; tight skin; tingling; leakage; NRS: 0 = no complaints, 10 = the highest intensity) before the intervention and after treatment in both groups.
The assessment of compression comfort
Time frame: 14 months
Patients rated their comfort and complications related to compression on a numerical rating scale (NRS) based on the International Compression Club (ICC) Questionnaire - Part for Patients. Complications of compression related to skin irritation; tender spots; skin damage; itching; warmth; throbbing; cramps; cutting in; slippage; local swelling; bulky feeling; too tight feeling (NRS: 0 = not present at all, 10 = very obviously present, sum of points) were assessed after treatment in both groups. Compression comfort including: easy donning; easy doffing; feeling immediately after donning; feeling during daytime; putting on clothes on compression; feeling at night; the appearance of the garment (NRS: 0 = not able at all, 10 = completely able, sum of points) was evaluated after treatment in both groups.
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 7 Aug 2025.
- Background: PubMed 30607986Pujol-Blaya V, Salinas-Huertas S, Catasus ML, Pascual T, Belmonte R. Effectiveness of a precast adjustable compression system compared to multilayered compression bandages in the treatment of breast cancer-related lymphoedema: a randomized, single-blind clinical trial. Clin Rehabil. 2019 Apr;33(4):631-641. doi: 10.1177/0269215518821785. Epub 2019 Jan 4.
- Results publication: PubMed 37106735Ochalek K, Kurpiewska J, Gradalski T. Adjustable Compression Wraps (ACW) vs. Compression Bandaging (CB) in the Acute Phase of Breast Cancer-Related Arm Lymphedema Management-A Prospective Randomized Study. Biology (Basel). 2023 Mar 31;12(4):534. doi: 10.3390/biology12040534.
- Effectiveness of a precast adjustable compression system compared to multilayerd compression bandaging in the treatment of breast cancer-related lymphedemaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. * limb volume reduction * physical functioning * disease- related symptoms * comfort in compression
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adjustable compression device (type circaid® reduction kit, Medi-Bayreuth) and Comparison of inelastic compression efficiency in people with Lymphedema and Lymphedema Arm, run by University School of Physical Education, Krakow, Poland at 1 site in Poland.
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 4 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 7 Aug 2025. 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 Poland. 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?
The assessment of limb volume (time frame: 14 months). The study lists 4 primary outcomes in all. 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 NCT07109674, which also lists 2 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 7 Aug 2025.