Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549738
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Effects of Intermittent Pneumatic Compression Therapy on Tissue Volume Pain and Quality of Life in Lipedema
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Intermittent Pneumatic Compression Therapy on Tissue Volume Pain and Quality of Life in Women Living With Lipedema
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lipedema is an inflammatory and painful disease of subcutaneous adipose tissue SAT in women that is associated with vein disease and lymphedema There is controversy on whether there is edema in lipedema This study seeks to determine 1 Is there is edema in lipedema 2 Can edema lipedema subcutaneous adipose tissue SAT symptoms and quality of life be improved by an advanced intermittent pneumatic compression device IPCD
During the course of the study subjects will be seen three times in the clinic for assessment and measurements All subjects will be provided a compression legging at the first clinic visit Half of the subjects the treatment group will be provided and use an advanced intermittent pneumatic compression device with pants-type appliance that applies dynamic compression therapy to the abdomen hips buttocks legs and feet starting at the second visit for 30 days at home along with daytime use of the compression legging The other half the control group will use the compression leggings only At the third visit final measurements will be obtained The measurements in the study include volume measurements using tape measure and a scanner body composition measurements bioimpedance ultrasound and biopsy of the skin timed walking and gait measurements and questionnaires about pain and quality of life Deidentified without names patient medical records will be examined for information on vein disease body mass index weight age and stage of lipedema any stage or type After the third visit results will be analyzed
During the course of the study subjects will be seen three times in the clinic for assessment and measurements All subjects will be provided a compression legging at the first clinic visit Half of the subjects the treatment group will be provided and use an advanced intermittent pneumatic compression device with pants-type appliance that applies dynamic compression therapy to the abdomen hips buttocks legs and feet starting at the second visit for 30 days at home along with daytime use of the compression legging The other half the control group will use the compression leggings only At the third visit final measurements will be obtained The measurements in the study include volume measurements using tape measure and a scanner body composition measurements bioimpedance ultrasound and biopsy of the skin timed walking and gait measurements and questionnaires about pain and quality of life Deidentified without names patient medical records will be examined for information on vein disease body mass index weight age and stage of lipedema any stage or type After the third visit results will be analyzed
Detailed Description:
Introduction Lipedema is a disease of loose connective adipose tissue that has no known cause or cure One of the main features is an increased amount of abnormal fibrotic subcutaneous adipose tissue SAT deposited in the legs pelvis abdomen andor arms of women
Management options for lipedema focus on improving lymphatic flow controlling edema swelling reducing pain or discomfort and deep tissue therapy to try and reduce fibrosis Intermittent pneumatic compression devices IPCDs are externally applied pumps that reduce leg swelling and improve pain and quality of life for patients with lipedema
No study has demonstrated an improvement in fat volume relative to total leg volume fascia quality and fibrosis of the leg after the use of IPCDs
The goal of this study is to improve our understanding of lipedema tissue and how use of the IPCD Lympha Press Optimal Plus with Lympha Pants garments may improve tissue volume fluid quality quality of life and pain levels in women with lipedema
This is a randomized controlled study of 50 women with lipedema with 25 women in the Treatment group and 25 women in the Control group Women with lipedema will be recruited from women with lipedema who have had their vein disease treated Women in this part of the study will therefore have only lipedema without active treatable vein disease Both legs of all enrolled women will be studied for a total of 100 legs evaluated All participants in the Treatment group will be supplied the Lympha Press Optimal Plus IPCD and the Lympha Pants garment to treat the lower body including the abdomen pelvis and buttocks trunk and the lower extremities All participants in the study Treatment and Controls will receive compression leggings and will be instructed to wear them daily
Primary Aims
After use of Lympha Press Lympha Pants for 30 days changes will be assessed in
1 Leg and abdominal tissue volume
2 Leg and abdominal fluid volume
3 Pain level
4 Quality of life
Secondary Aim 1
After use of the Lympha Press Lympha Pants for 30 consecutive days the following changes will be assessed
1 Tissue microvasculature
2 Mobility
Secondary Aim 2
Assess the size andor degree of insufficiency of the greater and lesser veins of the legs of women with lipedema
Investigational Aims
After use of the Lympha Press Lympha Pants for 30 consecutive days the following changes will be assessed
1 Hyaluronic acid and other GAG levels in the blood
2 GAG levels in adipose tissue
3 Percentage of leaky vessels in the skin
4 Tissue fascia quality
5 Tissue fibrosis
Hypotheses
Hypotheses for Primary Aims
Use of the Lympha Press Optimal Plus with Lympha Pants for 30 consecutive days will
1 Reduce size or volume of SAT measured by
1 Ultrasound assessment of adipose tissue depth
2 Circumferential measurement every 10 cm from the ankle to the upper thigh using a measuring board This will be done at the same time each day
3 Natural smallest waist with a vertical measurement to the umbilicus and waist and hip circumferential measurements following WHO guidelines
4 Volumetric measurement LymphaTech Georgia using a validated three-dimensional scanner handheld device
5 Caliper measurements under the umbilicus on the anterior thigh and medial thigh as previously measured in women with lipedema
2 Reduce trunk and leg fluid volume measured by bioimpedance analyses BIA SoZo Digital Health Platform Impedimed Company San Diego California
3 Reduce pain measured by a visual analogue scale
3 Improve quality of life measured by the following two validated questionnaires
1 RAND Rand Healthcare Randorg 36-Item Health Survey 10 SF-36
2 Lower extremity functional scale LEFS
Hypotheses for Secondary Aims Secondary Aim 1
Use of the Lympha Press Lympha Pants for 30 consecutive days will
Improve micro-vessel structure measured by
1 Biopsy of the skin Skin biopsies have previously shown that blood vessels in the dermis are oriented in a perpendicular manner to the plane of the skin suggestive of inflammation These vessels may revert back to their normal orientation due to reduction of inflammation fibrosis and GAGs in the skin
2 Thermography We will assess changes in tissue microvasculature after use of the Lympha Press Optimal Plus with Lympha Pants by thermography photos FLIR of the legs and hypothesize a decrease in the overall number of visible vessels The room temperature must be constant for repeat measurements Non-thermogenic regular photos will also be taken in case body contours need to be assessed to determine locations of brighter spots in the photos representing dilated blood vessels
3 Mobility Women with lipedema very often have mobility limitations We anticipate that women who initially have limited mobility will improve after using the Lympha Press Optimal Plus for 30 days at home Mobility will be measured by
1 The Timed up and Go TUG test
2 Quantitative assessment of their walk several times across a special walking mat GAITRite that records and analyzes the pattern of their footsteps
Secondary Aim 2
Vein Disease - Chart Review Study We hypothesize that there will be enlarged veins in women with lipedema with minimal venous insufficiency based on unpublished studies and previous anecdotal clinical assessments In addition to data collected on veins in these women we will collect body mass index weight age and stage of lipedema any stage or type No protected health information will be collected
Hypotheses for Investigational Aims
The use of Lympha Press Lympha Pants after 30 consecutive days will
1 Improve tissue fascia quality The integrity and quality of SAT superficial and deep fascia layers will be assessed by visual analogue scale analysis of ultrasound images by three independent reviewers Images from a previous study will be used to create a 5-point scale of fascia quality which the reviewers will use to assess fascia quality from tissue ultrasounds obtained from our study subjects
2 Decrease tissue fibrosis SAT fibrosis will be measured by
1 Echogenicity of SAT and muscle
2 Tissue Rigidity Assessment
Subject Use of the Lympha Press Pump at Home The subjects will use the Lympha Press pump at home at least once a day for 30 days
Day 30 Final Visit - 2 days After 30 consecutive days of daily home use of the Lympha Press Optimal Plus with Lympha Pants legs will be assessed
IPCD Treatment one hour Lympha Press Treatment While IPCD treatment takes place subjects will be educated on the use of the IPCD and the protocol they will follow for the home treatment phase During the hour-long treatment session in the clinic the pressure will be gradually increased per subject tolerance starting at 20 mm Hg
Measures documented from the chart study including the venous duplex ultrasound exam
1 Age
2 Height
3 Weight
4 Surgical history
5 Medical history
6 Family history
7 Allergies
8 Vein reflux sapheno-femoral junction proximal GSV GSV knee GSV distal sapheno-popliteal junction superficial saphenous vein SSV proximal
9 Vein size sapheno-femoral junction proximal GSV GSV knee GSV distal sapheno-popliteal junction superficial saphenous vein SSV proximal
10 Treatment for the GSV or SSV
11 Clinical C Etiological E Anatomical A and Pathophysiological P classification of the veins
Expected outcomes of the study
Lipedema has no known cure and few treatment options are available IPCDs have been used to manage this disease for years and have been shown to be a promising option for treatment We anticipate the following outcomes
1 Publication on venous disease in women with lipedema
2 Publication on effects of the Lympha Press Optimal Plus Pump and Lympha Pants garments on
1 Tissue volume
2 Pain
3 Quality of life
4 Mobility
3 Publication on the effect of the Lympha Press Optimal Plus and Lympha Pants garments on fibrosis in lipedema adipose tissue
Data management and statistical analysis Confidentiality of all subjects will be strictly protected Each patient will have an assigned patient ID no names or dates of birth will be included in the database The information that makes the patient identifiable will only be available to the researchers handling the information and this information will be destroyed after 6 years
Statistics Overarching Data Analyses Data will be collected on an excel spreadsheet and imported into GraphPad PRISM for statistical purposes and graphing Data will only use subject numbers Data from each visit such as volume BIA SAT thickness VAS pain scores caliper measurements GAITrite and TUG data will be averaged for each data point and either described in the text of the publication or compared to other data points using paired t-tests or repeated measures ANOVA Significance will be set at α005
RAND 36-Item Health Survey 10 Data from the RAND 36-Item Health Survey 10 will be input into an excel spreadsheet The RAND 36-Item Health Survey 10 assesses eight health concepts physical functioning bodily pain role limitations due to physical health problems role limitations due to personal or emotional problems emotional well-being social functioning energyfatigue and general health perceptions It also includes a single item that provides an indication of perceived change in health
Management options for lipedema focus on improving lymphatic flow controlling edema swelling reducing pain or discomfort and deep tissue therapy to try and reduce fibrosis Intermittent pneumatic compression devices IPCDs are externally applied pumps that reduce leg swelling and improve pain and quality of life for patients with lipedema
No study has demonstrated an improvement in fat volume relative to total leg volume fascia quality and fibrosis of the leg after the use of IPCDs
The goal of this study is to improve our understanding of lipedema tissue and how use of the IPCD Lympha Press Optimal Plus with Lympha Pants garments may improve tissue volume fluid quality quality of life and pain levels in women with lipedema
This is a randomized controlled study of 50 women with lipedema with 25 women in the Treatment group and 25 women in the Control group Women with lipedema will be recruited from women with lipedema who have had their vein disease treated Women in this part of the study will therefore have only lipedema without active treatable vein disease Both legs of all enrolled women will be studied for a total of 100 legs evaluated All participants in the Treatment group will be supplied the Lympha Press Optimal Plus IPCD and the Lympha Pants garment to treat the lower body including the abdomen pelvis and buttocks trunk and the lower extremities All participants in the study Treatment and Controls will receive compression leggings and will be instructed to wear them daily
Primary Aims
After use of Lympha Press Lympha Pants for 30 days changes will be assessed in
1 Leg and abdominal tissue volume
2 Leg and abdominal fluid volume
3 Pain level
4 Quality of life
Secondary Aim 1
After use of the Lympha Press Lympha Pants for 30 consecutive days the following changes will be assessed
1 Tissue microvasculature
2 Mobility
Secondary Aim 2
Assess the size andor degree of insufficiency of the greater and lesser veins of the legs of women with lipedema
Investigational Aims
After use of the Lympha Press Lympha Pants for 30 consecutive days the following changes will be assessed
1 Hyaluronic acid and other GAG levels in the blood
2 GAG levels in adipose tissue
3 Percentage of leaky vessels in the skin
4 Tissue fascia quality
5 Tissue fibrosis
Hypotheses
Hypotheses for Primary Aims
Use of the Lympha Press Optimal Plus with Lympha Pants for 30 consecutive days will
1 Reduce size or volume of SAT measured by
1 Ultrasound assessment of adipose tissue depth
2 Circumferential measurement every 10 cm from the ankle to the upper thigh using a measuring board This will be done at the same time each day
3 Natural smallest waist with a vertical measurement to the umbilicus and waist and hip circumferential measurements following WHO guidelines
4 Volumetric measurement LymphaTech Georgia using a validated three-dimensional scanner handheld device
5 Caliper measurements under the umbilicus on the anterior thigh and medial thigh as previously measured in women with lipedema
2 Reduce trunk and leg fluid volume measured by bioimpedance analyses BIA SoZo Digital Health Platform Impedimed Company San Diego California
3 Reduce pain measured by a visual analogue scale
3 Improve quality of life measured by the following two validated questionnaires
1 RAND Rand Healthcare Randorg 36-Item Health Survey 10 SF-36
2 Lower extremity functional scale LEFS
Hypotheses for Secondary Aims Secondary Aim 1
Use of the Lympha Press Lympha Pants for 30 consecutive days will
Improve micro-vessel structure measured by
1 Biopsy of the skin Skin biopsies have previously shown that blood vessels in the dermis are oriented in a perpendicular manner to the plane of the skin suggestive of inflammation These vessels may revert back to their normal orientation due to reduction of inflammation fibrosis and GAGs in the skin
2 Thermography We will assess changes in tissue microvasculature after use of the Lympha Press Optimal Plus with Lympha Pants by thermography photos FLIR of the legs and hypothesize a decrease in the overall number of visible vessels The room temperature must be constant for repeat measurements Non-thermogenic regular photos will also be taken in case body contours need to be assessed to determine locations of brighter spots in the photos representing dilated blood vessels
3 Mobility Women with lipedema very often have mobility limitations We anticipate that women who initially have limited mobility will improve after using the Lympha Press Optimal Plus for 30 days at home Mobility will be measured by
1 The Timed up and Go TUG test
2 Quantitative assessment of their walk several times across a special walking mat GAITRite that records and analyzes the pattern of their footsteps
Secondary Aim 2
Vein Disease - Chart Review Study We hypothesize that there will be enlarged veins in women with lipedema with minimal venous insufficiency based on unpublished studies and previous anecdotal clinical assessments In addition to data collected on veins in these women we will collect body mass index weight age and stage of lipedema any stage or type No protected health information will be collected
Hypotheses for Investigational Aims
The use of Lympha Press Lympha Pants after 30 consecutive days will
1 Improve tissue fascia quality The integrity and quality of SAT superficial and deep fascia layers will be assessed by visual analogue scale analysis of ultrasound images by three independent reviewers Images from a previous study will be used to create a 5-point scale of fascia quality which the reviewers will use to assess fascia quality from tissue ultrasounds obtained from our study subjects
2 Decrease tissue fibrosis SAT fibrosis will be measured by
1 Echogenicity of SAT and muscle
2 Tissue Rigidity Assessment
Subject Use of the Lympha Press Pump at Home The subjects will use the Lympha Press pump at home at least once a day for 30 days
Day 30 Final Visit - 2 days After 30 consecutive days of daily home use of the Lympha Press Optimal Plus with Lympha Pants legs will be assessed
IPCD Treatment one hour Lympha Press Treatment While IPCD treatment takes place subjects will be educated on the use of the IPCD and the protocol they will follow for the home treatment phase During the hour-long treatment session in the clinic the pressure will be gradually increased per subject tolerance starting at 20 mm Hg
Measures documented from the chart study including the venous duplex ultrasound exam
1 Age
2 Height
3 Weight
4 Surgical history
5 Medical history
6 Family history
7 Allergies
8 Vein reflux sapheno-femoral junction proximal GSV GSV knee GSV distal sapheno-popliteal junction superficial saphenous vein SSV proximal
9 Vein size sapheno-femoral junction proximal GSV GSV knee GSV distal sapheno-popliteal junction superficial saphenous vein SSV proximal
10 Treatment for the GSV or SSV
11 Clinical C Etiological E Anatomical A and Pathophysiological P classification of the veins
Expected outcomes of the study
Lipedema has no known cure and few treatment options are available IPCDs have been used to manage this disease for years and have been shown to be a promising option for treatment We anticipate the following outcomes
1 Publication on venous disease in women with lipedema
2 Publication on effects of the Lympha Press Optimal Plus Pump and Lympha Pants garments on
1 Tissue volume
2 Pain
3 Quality of life
4 Mobility
3 Publication on the effect of the Lympha Press Optimal Plus and Lympha Pants garments on fibrosis in lipedema adipose tissue
Data management and statistical analysis Confidentiality of all subjects will be strictly protected Each patient will have an assigned patient ID no names or dates of birth will be included in the database The information that makes the patient identifiable will only be available to the researchers handling the information and this information will be destroyed after 6 years
Statistics Overarching Data Analyses Data will be collected on an excel spreadsheet and imported into GraphPad PRISM for statistical purposes and graphing Data will only use subject numbers Data from each visit such as volume BIA SAT thickness VAS pain scores caliper measurements GAITrite and TUG data will be averaged for each data point and either described in the text of the publication or compared to other data points using paired t-tests or repeated measures ANOVA Significance will be set at α005
RAND 36-Item Health Survey 10 Data from the RAND 36-Item Health Survey 10 will be input into an excel spreadsheet The RAND 36-Item Health Survey 10 assesses eight health concepts physical functioning bodily pain role limitations due to physical health problems role limitations due to personal or emotional problems emotional well-being social functioning energyfatigue and general health perceptions It also includes a single item that provides an indication of perceived change in health
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None