Intermittent Pneumatic Compression in Women With Lipo-lymphedema (Lipedema With Swelling)

• Sponsor: Thomas Wright, MD (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04213989
• Collaborator: Tactile Medical (Industry)
• Enrollment: 36
• Location: 1
• Arms: 2
• Actual Duration (Months): 21.8
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

Lipedema is a connective tissue disorder that affects up to 10% of women. It is characterized by painful, swollen subcutaneous tissue and disproportionate fat accumulation (primarily in the lower limbs, however it can spread to the abdomen and arms). Patients are often not aware they are affected by this disease; rather, they think they are just overweight or obese.

Patients with lipedema often feel frustrated and uncomfortable as symptoms such as heaviness, pain, and easy bruising impact quality of life. Affected limbs can become so large and heavy that daily tasks such as walking, cleaning, or shopping become impossible.

There is currently no cure for lipedema, thus treatment focuses on symptom management and improved patient-reported outcomes. At present, the two main courses of treatment include non-surgical conservative treatment (e.g., Comprehensive Decongestive Therapy (CDT), diet, exercise, emotional/psychological/social support) and lymph-sparing liposuction performed by a surgeon trained in lipedema treatment. The primary goals for treatment include: reduction/elimination of inflammation, swelling, and pain; increase in lymphatic flow, which reduces/eliminates excessive fluid and swelling; overall management of the physical impact of lipedema; and quality of life improvements which can include emotional, psychological/mental, spiritual, and social enhancement in addition to physical management.

Intermittent Pneumatic Compression (IPC) devices are often used as home-therapy to treat secondary lymphedema or lipo-lymphedema (lipedema with swelling) and may be helpful in preventing the progression of lipedema. IPC use moves lymphatic fluid and supports the elimination of proteinaceous fluids, thus leading to improved patient-reported symptoms, decreased limb girth and volume, increased elasticity of tissues, and fewer episodes of infection.

The purpose of this study is to assess whether 3-4 weeks of IPC usage is associated with alleviation of symptoms and improvement in quality of life in women with lipo-lymphedema (lipedema with swelling).

Condition or Disease	Intervention/Treatment	Phase
Lipedema; Lipolymphedema	Device: Flexitouch Plus and Conservative Care; Other: Conservative Care	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Eligible patients will be randomized to conservative care or Flexitouch Plus and conservative care at Screening. Subjects have up to 60 days to acquire treatment through commercial means and commence treatment. Follow-up will take place 3-4 weeks after treatment commences.Eligible patients will be randomized to conservative care or Flexitouch Plus and conservative care at Screening. Subjects have up to 60 days to acquire treatment through commercial means and commence treatment. Follow-up will take place 3-4 weeks after treatment commences.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: An Investigator-initiated Study Assessing the Effect of Intermittent Pneumatic Compression (IPC) on Symptoms and Quality of Life in Women With Lipo-lymphedema (Lipedema With Swelling)
• Actual Study Start Date: Jan 31, 2020
• Actual Primary Completion Date: Nov 24, 2021
• Actual Study Completion Date: Nov 24, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conservative Care Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT)	Other: Conservative Care; May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
Experimental: Flexitouch Plus and Conservative Care Flexitouch Plus with conservative care	Device: Flexitouch Plus and Conservative Care; A segmental, programmable, gradient advanced pneumatic compression device. The system consists of a controller unit and garments, and provides in-home manual lymphatic drainage therapy in the legs for approximately 1 hour daily. Conservative care may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.; Other Names: Flexitouch system

Outcome Measures

Primary Outcome Measures

1. Change in Circumferential Measurements Over Time [Changes between Screening and 3-4 weeks will be assessed]

   Tape measurements along both legs

2. Patient-Reported Quality of Life [Changes between Screening and 3-4 weeks will be assessed]

   RAND 36-Item Short Form Survey Instrument (SF-36) 1.0 is a global assessment of health impacts on quality of life that taps 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, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.

3. Patient-Reported Pain Interference [Changes between Screening and 3-4 weeks will be assessed]

   PROMIS Item Bank v1.0 - Pain Interference - Short Form 6b is a 6 item survey that measures self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. All items are scored so that a low score is associated with less pain interference (a more favorable health state). In addition, each item is scored on a 1 to 5 range so that the lowest and highest possible scores are 6 and 30, respectively.

4. Patient-Reported Pain [Changes between Screening and 3-4 weeks will be assessed]

   Wong Baker Faces Scale is a self-assessment tool that is easily understood by patients, so they are able to choose the face that best illustrates the physical pain they are experiencing associated with their lipo-lymphedema. Face 0 doesn't hurt at all. Face 2 hurts just a little bit. Face 4 hurts a little bit more. Face 6 hurts even more. Face 8 hurts a whole lot. Face 10 hurts as much as you can imagine, although you don't have to be crying to have this worst pain.

5. Patient-Reported Symptoms of Lipo-Lymphedema [Changes between Screening and 3-4 weeks will be assessed]

   NRS Symptom Survey is a 6-item survey that asks patients to rate their perceptions of swelling, heaviness, pain, fatigue, tenderness, and tightness independently for each leg using a 10-point numerical rating scale where 0 represents none/not present and 10 is worst imaginable. All items are scored so that a low score is associated with fewer symptoms (defines a more favorable health state). The lowest and highest possible scores per leg are 0 and 60, respectively, with a combined total score between 0 and 120.

Secondary Outcome Measures

1. Patient-Reported Mobility [Changes between Screening and 3-4 weeks will be assessed]

   PROMIS Item Bank v2.0 - Mobility is a 15-item survey that focuses on activities of physical mobility such as getting out of bed or a chair to activities such as running. All items are scored so that a high score is associated with more mobility (a more favorable health state). In addition, each item is scored on a 5 to 1 range so that the highest and lowest possible scores are 75 and 15, respectively.

2. Change in Bioimpedance Measurements Over Time [Changes between Screening and 3-4 weeks will be assessed]

   InBody 770 whole body and segmental extracorporeal body weight / total body weight ratios

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Female age 18-70 years

• Stage 2-3 (Schmeller Type 2-3) lipedema with secondary lymphedema

• Willing and able to follow prescribed care for study period

• Able to access (via self-pay, patient assistance, or insurance programs) prescribed care within 60 days of Screening visit

Exclusion Criteria:

• BMI > 50

• Heart failure (acute pulmonary edema, decompensated acute heart failure)

• Pacemaker or implantable cardioverter defibrillator (ICD)

• Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)

• Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds, or gangrene)

• Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) on the arms or trunk

• Active cancer (cancer that is currently under treatment, but not yet in remission)

• Poorly controlled kidney disease (glomerular filtration rate < 30 mls per minute), hypoproteinemia, pulmonary hypertension, hypothyroidism, cyclic edema, or Munchausen Syndrome

• Any circumstance where increased lymphatic or venous return is undesirable

• Currently pregnant or trying to become pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laser Lipo and Vein Center	O'Fallon	Missouri	United States	63368

Sponsors and Collaborators

• Thomas Wright, MD
• Tactile Medical

Investigators

• Principal Investigator: Thomas Wright, MD, Lakeview Medical Group, Inc

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 11, 2020

More Information

Publications

None provided.

• Responsible Party: Thomas Wright, MD, MD, FACPh, FACP, RVT, Tactile Medical
• ClinicalTrials.gov Identifier: NCT04213989
• Other Study ID Numbers: 1000
• First Posted: Dec 30, 2019
• Last Update Posted: Aug 23, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Lymphedema; Lipedema

Study Results

Participant Flow

Arm/Group Title	Conservative Care	Flexitouch Plus and Conservative Care
Arm/Group Description	Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT) Conservative Care: May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.	Flexitouch Plus with conservative care Flexitouch Plus and Conservative Care: A segmental, programmable, gradient advanced pneumatic compression device. The system consists of a controller unit and garments, and provides in-home manual lymphatic drainage therapy in the legs for approximately 1 hour daily. Conservative care may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
Period Title: Overall Study
STARTED	18	18
COMPLETED	14	12
NOT COMPLETED	4	6

Baseline Characteristics

Arm/Group Title	Conservative Care	Flexitouch Plus and Conservative Care	Total
Arm/Group Description	Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT) Conservative Care: May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.	Flexitouch Plus with conservative care Flexitouch Plus and Conservative Care: A segmental, programmable, gradient advanced pneumatic compression device. The system consists of a controller unit and garments, and provides in-home manual lymphatic drainage therapy in the legs for approximately 1 hour daily. Conservative care may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.	Total of all reporting groups
Overall Participants	14	12	26
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.1 (9.6)	44.6 (9.5)	43.3 (9.4)
Sex: Female, Male (Count of Participants)
Female	14 100%	12 100%	26 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	14 100%	12 100%	26 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 7.1%	0 0%	1 3.8%
White	12 85.7%	12 100%	24 92.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 7.1%	0 0%	1 3.8%
Region of Enrollment (participants) [Number]
United States	14 100%	12 100%	26 100%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	37.0 (7.5)	35.9 (5.2)	36.5 (6.4)

Outcome Measures

1. Primary Outcome

Title	Change in Circumferential Measurements Over Time
Description	Tape measurements along both legs
Time Frame	Changes between Screening and 3-4 weeks will be assessed

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conservative Care	Flexitouch Plus and Conservative Care
Arm/Group Description	Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT) Conservative Care: May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.	Flexitouch Plus with conservative care Flexitouch Plus and Conservative Care: A segmental, programmable, gradient advanced pneumatic compression device. The system consists of a controller unit and garments, and provides in-home manual lymphatic drainage therapy in the legs for approximately 1 hour daily. Conservative care may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
Measure Participants	14	12
Measure Legs	28	24
Ankle	-0.5	-1.0
Calf	-1.3	-2.0
Knee	-2.4	-4.7
Thigh	-1.7	-3.0
Hip	-0.4	3.2
Waist	-2.4	-2.3

2. Primary Outcome

Title	Patient-Reported Quality of Life
Description	RAND 36-Item Short Form Survey Instrument (SF-36) 1.0 is a global assessment of health impacts on quality of life that taps 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, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Time Frame	Changes between Screening and 3-4 weeks will be assessed

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conservative Care	Flexitouch Plus and Conservative Care
Arm/Group Description	Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT) Conservative Care: May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.	Flexitouch Plus with conservative care Flexitouch Plus and Conservative Care: A segmental, programmable, gradient advanced pneumatic compression device. The system consists of a controller unit and garments, and provides in-home manual lymphatic drainage therapy in the legs for approximately 1 hour daily. Conservative care may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
Measure Participants	14	12
General health	-2.7	1.3
Physical functioning	2.6	5.3
Role limitations due to physical functioning	-1.2	1.4
Emotional wellbeing	2.8	-1.0
Role limitations due to emotional problems	-10.9	-2.2
Energy/fatigue	4.8	0.7
Social functioning	9.9	-2.2
Pain	4.5	10.2

3. Primary Outcome

Title	Patient-Reported Pain Interference
Description	PROMIS Item Bank v1.0 - Pain Interference - Short Form 6b is a 6 item survey that measures self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. All items are scored so that a low score is associated with less pain interference (a more favorable health state). In addition, each item is scored on a 1 to 5 range so that the lowest and highest possible scores are 6 and 30, respectively.
Time Frame	Changes between Screening and 3-4 weeks will be assessed

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conservative Care	Flexitouch Plus and Conservative Care
Arm/Group Description	Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT) Conservative Care: May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.	Flexitouch Plus with conservative care Flexitouch Plus and Conservative Care: A segmental, programmable, gradient advanced pneumatic compression device. The system consists of a controller unit and garments, and provides in-home manual lymphatic drainage therapy in the legs for approximately 1 hour daily. Conservative care may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
Measure Participants	14	12
Mean (95% Confidence Interval) [score on a scale]	-1.4	-3.0

4. Primary Outcome

Title	Patient-Reported Pain
Description	Wong Baker Faces Scale is a self-assessment tool that is easily understood by patients, so they are able to choose the face that best illustrates the physical pain they are experiencing associated with their lipo-lymphedema. Face 0 doesn't hurt at all. Face 2 hurts just a little bit. Face 4 hurts a little bit more. Face 6 hurts even more. Face 8 hurts a whole lot. Face 10 hurts as much as you can imagine, although you don't have to be crying to have this worst pain.
Time Frame	Changes between Screening and 3-4 weeks will be assessed

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conservative Care	Flexitouch Plus and Conservative Care
Arm/Group Description	Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT) Conservative Care: May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.	Flexitouch Plus with conservative care Flexitouch Plus and Conservative Care: A segmental, programmable, gradient advanced pneumatic compression device. The system consists of a controller unit and garments, and provides in-home manual lymphatic drainage therapy in the legs for approximately 1 hour daily. Conservative care may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
Measure Participants	14	12
Mean (95% Confidence Interval) [score on a scale]	-0.8	-0.8

5. Primary Outcome

Title	Patient-Reported Symptoms of Lipo-Lymphedema
Description	NRS Symptom Survey is a 6-item survey that asks patients to rate their perceptions of swelling, heaviness, pain, fatigue, tenderness, and tightness independently for each leg using a 10-point numerical rating scale where 0 represents none/not present and 10 is worst imaginable. All items are scored so that a low score is associated with fewer symptoms (defines a more favorable health state). The lowest and highest possible scores per leg are 0 and 60, respectively, with a combined total score between 0 and 120.
Time Frame	Changes between Screening and 3-4 weeks will be assessed

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conservative Care	Flexitouch Plus and Conservative Care
Arm/Group Description	Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT) Conservative Care: May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.	Flexitouch Plus with conservative care Flexitouch Plus and Conservative Care: A segmental, programmable, gradient advanced pneumatic compression device. The system consists of a controller unit and garments, and provides in-home manual lymphatic drainage therapy in the legs for approximately 1 hour daily. Conservative care may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
Measure Participants	14	12
Swelling-Left Leg	-0.5	-0.2
Heaviness-Left Leg	-0.9	-1.0
Pain-Left Leg	-0.3	-1.4
Fatigue-Left Leg	-1.4	-0.6
Tenderness-Left Leg	-0.6	-0.2
Tightness-Left Leg	-1.2	-1.8
Swelling-Right Leg	-0.7	0.1
Heaviness-Right Leg	-0.8	-0.5
Pain-Right Leg	-0.1	-0.5
Fatigue-Right Leg	-1.8	-0.3
Tenderness-Right Leg	-0.1	0.1
Tightness-Right Leg	-0.9	-1.6

6. Secondary Outcome

Title	Patient-Reported Mobility
Description	PROMIS Item Bank v2.0 - Mobility is a 15-item survey that focuses on activities of physical mobility such as getting out of bed or a chair to activities such as running. All items are scored so that a high score is associated with more mobility (a more favorable health state). In addition, each item is scored on a 5 to 1 range so that the highest and lowest possible scores are 75 and 15, respectively.
Time Frame	Changes between Screening and 3-4 weeks will be assessed

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conservative Care	Flexitouch Plus and Conservative Care
Arm/Group Description	Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT) Conservative Care: May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.	Flexitouch Plus with conservative care Flexitouch Plus and Conservative Care: A segmental, programmable, gradient advanced pneumatic compression device. The system consists of a controller unit and garments, and provides in-home manual lymphatic drainage therapy in the legs for approximately 1 hour daily. Conservative care may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
Measure Participants	14	12
Mean (95% Confidence Interval) [score on a scale]	2.9	-0.6

7. Secondary Outcome

Title	Change in Bioimpedance Measurements Over Time
Description	InBody 770 whole body and segmental extracorporeal body weight / total body weight ratios
Time Frame	Changes between Screening and 3-4 weeks will be assessed

Outcome Measure Data

Analysis Population Description

Each participant underwent circumferential measurement at baseline and at follow-up. Patients were measured at 4 sites on each leg (narrowest part of the ankle, largest part of the calf, top of knee cap, and thickest part of the upper thigh), the widest part of the hips and the widest part of the waist.

Arm/Group Title	Conservative Care	Flexitouch Plus and Conservative Care
Arm/Group Description	Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT) Conservative Care: May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.	Flexitouch Plus with conservative care Flexitouch Plus and Conservative Care: A segmental, programmable, gradient advanced pneumatic compression device. The system consists of a controller unit and garments, and provides in-home manual lymphatic drainage therapy in the legs for approximately 1 hour daily. Conservative care may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
Measure Participants	14	12
Whole body	-0.001	-0.002
Trunk	-0.001	-0.002
Arms	0.000	0.000
Legs	-0.003	-0.004

Adverse Events

Time Frame	12 weeks
Adverse Event Reporting Description	This study collected data on serious and device-related adverse events only. Non-serious adverse events were not required to reported and / or moniotred.
Arm/Group Title	Conservative Care		Flexitouch Plus and Conservative Care
Arm/Group Description	Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT) Conservative Care: May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.		Flexitouch Plus with conservative care Flexitouch Plus and Conservative Care: A segmental, programmable, gradient advanced pneumatic compression device. The system consists of a controller unit and garments, and provides in-home manual lymphatic drainage therapy in the legs for approximately 1 hour daily. Conservative care may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
All Cause Mortality
	Conservative Care		Flexitouch Plus and Conservative Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/12 (0%)
Serious Adverse Events
	Conservative Care		Flexitouch Plus and Conservative Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Conservative Care		Flexitouch Plus and Conservative Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.