MIST Ultrasound Therapy Compared to United Kingdom Standard Care for the Treatment of Non-healing Venous Leg Ulcers

• Sponsor: Cardiff and Vale University Health Board (Other)
• Overall Status: Completed
• CT.gov ID: NCT01671748
• Collaborator: Celleration, Inc. (Industry)
• Enrollment: 47
• Location: 1
• Arms: 2
• Duration (Months): 16
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

Chronic venous leg ulcers (VLUs) impact negatively on patients' quality of life. Standard treatment in the UK for patients with VLUs is compression bandaging or stockings. The MIST ultrasound system is a noncontact device which delivers low frequency ultrasound through a gentle saline mist directed at a patient's wound. This study aims to determine whether the use of the MIST device used in combination with standard treatments can improve healing of VLUs compared to UK standard practice. This will be assessed by measuring any reduction in wound size in the two groups after receiving 8 weeks of either Standard Care once a week or MIST combined with Standard Care three times a week.

Condition or Disease	Intervention/Treatment	Phase
Varicose Ulcer	Device: MIST ultrasound therapy; Other: Standard Care	N/A

Detailed Description

Venous leg ulcers (VLUs) are wounds which are often chronic and difficult to heal. VLUs affect between 1 and 3.2 people per 1000; they cause pain, reduced mobility and impact negatively on patients' quality of life (QoL). Standard treatment for patients with VLUs is the application of strong, sustained compression with bandages or stockings. This pragmatically-designed study aims to determine whether the use of a device called MIST used in combination with standard treatments can improve healing of VLUs compared to UK standard practice. It will also show whether the MIST regimen improves participants' QoL and reduces the incidence of infection.

The MIST ultrasound system is a non-contact device which delivers low-frequency ultrasound through a gentle saline mist directed at a patient's wound. Patients (over 18 years old) will be invited to take part in this study if they have had a VLU for 6 weeks or more, which measures between 5 and 100 cm^2, and is not infected. Participants with diabetes must show good blood glucose control, and those with underlying chronic disorders which may affect wound healing will be excluded.

All study participants will receive four weeks of standard treatment once a week at a single clinic at the Wound Healing Research Unit (WHRU), University Hospital of Wales. Patients whose wounds reduce by more than 40% during this time will be withdrawn from the study. Remaining patients will be randomly allocated to either the active group or the control group to receive a further eight weeks of treatment. Participants in the active group will receive treatment with the MIST device three times a week, as well as standard care (change of compression bandage and dressings) three times a week. The control group will receive UK standard care (which is dressing and compression bandage change at least once a week). The participants' ulcers will be measured and photographed once a week, and the wound characteristics will be assessed. Changes in participants' health related QoL will be assessed using a questionnaire at the beginning and end of the trial. Wound recurrence rates 90 days after the end of the treatment will be assessed by telephoning patients.

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pragmatic Randomised Controlled Trial of MIST Ultrasound Therapy Compared to UK Standard Care for the Treatment of Non-healing Venous Leg Ulcers.
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard Care Standard treatment for VLUs is administered once a week, i.e. compression bandaging and non-adherent dressing, with debridement if required.	Other: Standard Care; Compression bandaging, non-adherent dressing, and debridement if required.
Experimental: MIST and Standard Care MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.	Device: MIST ultrasound therapy; Low frequency, non-contact ultrasound system delivering therapeutic ultrasound via a fine saline mist to the wound bed.; Other Names: MIST non-contact low-frequecy ultrasound device MIST ; Other: Standard Care; Compression bandaging, non-adherent dressing, and debridement if required.

Outcome Measures

Primary Outcome Measures

1. Percentage Change in Wound Area [Week 5 to 13]

   Wound area is measured weekly using a digital wound imaging device. The wound boundary is digitally traced by a blinded assessor. Percentage and actual change in wound area between start of treatment (week 5) and end of treatment (week 13) is evaluated.

2. Actual Change in Wound Area [Week 5 to 13]

   Wound area is measured weekly using a digital wound imaging device. The wound boundary is digitally traced by a blinded assessor. Percentage and actual change in wound area between start of treatment (week 5) and end of treatment (week 13) is evaluated.

Secondary Outcome Measures

1. Change in Overall Health Related Quality of Life (HRQoL) From Week 1 (Start) and Week 13 (Exit) [Week 1 (start) and week 13 (exit)]

   On the first and final visit participants were invited to complete a Cardiff Wound Impact Schedule (CWIS) a validated questionnaire designed to measure the impact of chronic wounds on patient health-related quality of life (HRQoL). The overall HRQoL question asks patients to rate their overall quality of life over the past week by circling a number between 0 and 10. Low scores indicate poor quality of life, and high score indicate good quality of life. Change in HRQoL was calculated by subtracting week 1 values from week 13 values. CWIS has been validated in the following paper: Price and Harding (2004) The Cardiff Wound Impact Schedule: the development of a condition specific questionnaire to assess health-related quality of life in patients with chronic wounds. International Wound Journal 1(1):10-17

2. Change in Ulcer Pain Between Week 5 (Randomisation) and Week 13 (Exit) [Weeks 5 to 13]

   Pain was scored by each patient on a visual analogue score (VAS) from 0 to 100. A VAS score of 0 indicated no pain whilst a VAS score of 100 indicated worst possible pain. Change in pain scores were calculated by subtracting week 5 values from week 13 values.

3. Incidence of Wound Infection [Weeks 5 to 13]

   Median number of wound infections per patient (as demonstrated by clinical symptoms) from beginning of treatment (week 5) and end of treatment (week 13).

4. Number of Non-serious Adverse Events in Each Group [Week 5 to 13]

   Adverse events (AEs) were defined as any undesirable clinical occurrence in a subject whether it is thought to be related to the investigational device or not.

5. Wound Recurrence Rate [90 days after time of healing]

   Patients whose wound has healed (defined as 100% epithelialisation with no scab present) before or at the end of treatment will be asked 90 days after date of healing if their wound has remained closed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Venous leg ulcers (as diagnosed by the clinician)

• Ankle Brachial Pressure Index (ABPI) >0.8

• If multiple ulcers are present treat largest ulcer only (index ulcer) with minimum distance of 1 cm between index ulcer and any other ulcer

• 18 years or older

• Ulcer size of 5 cm^{2 - 100 cm}2 (with no longest length being greater than 10 cm) at randomisation point (week 5)

• Mobile enough to attend clinic

• Index ulcer between 6 weeks and 5 years duration prior to screening date

Exclusion Criteria:

• Uncontrolled diabetes (Hba1c ≥12%) as tested within the past 3 months

• Index ulcer has active infection on day of inclusion requiring use or oral or IV antibiotics

• Renal failure

• Index ulcer has exposed tendons, ligaments, muscle, or bone

• Osteomyelitis or cellulitis or gangrene in study limb

• Subjects with amputation above a trans metatarsal amputation (TMA) in the study limb

• Subjects with active malignancy on the study limb

• Index ulcer that is of arterial disease aetiology

• Females of child bearing potential who are not willing to use a method of highly effective contraception during the entire study

• Planned vascular surgery, angioplasty, or thrombolysis procedures within the study period, or 6 weeks post-operatively

• Planned surgical procedure during the study period for the index wound

• Prior skin replacement, negative pressure therapy, ultrasound therapy applied to the index wound 2 weeks before screening

• Oral or IV antibiotics within 48 hours of baseline measurements

• Growth factor therapy within previous 14 days of screening date

• Currently receiving or has received radiation or chemotherapy within 3 months of randomisation

• Pregnant or breast feeding women

• Subject is currently enrolled or has been enrolled in the last 30 days in another investigational device or drug trial

• Subject's wound would require ultrasound near an electronic implant or prosthesis

• Subjects lacking capacity to provide informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wound Healing Research Unit, Cardiff University	Cardiff		United Kingdom	CF14 4XN

Sponsors and Collaborators

• Cardiff and Vale University Health Board
• Celleration, Inc.

Investigators

• Principal Investigator: Keith G Harding, Professor, Wound Healing Research Unit, Cardiff University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Professor Keith G Harding, Director - Institute for Translation, Innovation, Methodology and Engagement (TIME), Cardiff University
• ClinicalTrials.gov Identifier: NCT01671748
• Other Study ID Numbers: 12-SUR-5323
• First Posted: Aug 24, 2012
• Last Update Posted: Aug 26, 2015
• Last Verified: Jul 1, 2015

• Keywords provided by Professor Keith G Harding, Director - Institute for Translation, Innovation, Methodology and Engagement (TIME), Cardiff University: Venous Leg Ulcer; Varicose Ulcer; Chronic ulcer; Chronic wound; Ultrasound therapy; MIST device; Wound healing; Low frequency non contact ultrasound
• Additional relevant MeSH terms: Varicose Ulcer; Leg Ulcer; Ulcer

Study Results

Participant Flow

Recruitment Details	Study procedures took place in a single dedicated unit specialising in wound healing research, between August 2012 and November 2013.
Pre-assignment Detail	All enrolled patients received 4 weeks of SOC prior to random allocation (run-in phase). Patients whose wounds reduced by >40% in the first 4 weeks were withdrawn and did not progress to random allocation.

Arm/Group Title	Standard of Care	NLFU and Standard of Care
Arm/Group Description	Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.	Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
Period Title: 4 Week run-in Phase
STARTED	47	0
COMPLETED	36	0
NOT COMPLETED	11	0
Period Title: 4 Week run-in Phase
STARTED	19	17
COMPLETED	19	17
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Standard of Care	NLFU and Standard of Care	Total
Arm/Group Description	Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.	Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.	Total of all reporting groups
Overall Participants	19	17	36
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.2 (12.2)	70.5 (12.7)	69 (12.0)
Sex: Female, Male (Count of Participants)
Female	12 63.2%	9 52.9%	21 58.3%
Male	7 36.8%	8 47.1%	15 41.7%
Region of Enrollment (participants) [Number]
United Kingdom	19 100%	17 100%	36 100%
History of leg ulceration (months) (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	94.7 (83.2)	109.7 (112.2)	101.8 (96.8)
Index ulcer duration (months) (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	22.3 (18.5)	15.7 (12.0)	19 (16)
Wound size at enrolment (cm^2) (cm^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm^2]	19.4 (14.9)	15.9 (9.9)	17.8 (12.7)
Change in wound size during run-in phase (%) (percentage change in wound area) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage change in wound area]	-13.0 (25.2)	-10.9 (23.9)	-12.0 (24.3)

Outcome Measures

1. Primary Outcome

Title	Percentage Change in Wound Area
Description	Wound area is measured weekly using a digital wound imaging device. The wound boundary is digitally traced by a blinded assessor. Percentage and actual change in wound area between start of treatment (week 5) and end of treatment (week 13) is evaluated.
Time Frame	Week 5 to 13

Outcome Measure Data

Analysis Population Description

All patients included in the analysis; Intention to treat (ITT); Values have been adjusted for the influence of the covariate (wound area at the start of treatment)

Arm/Group Title	Standard of Care	NLFU and Standard of Care
Arm/Group Description	Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.	Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
Measure Participants	19	17
Mean (Standard Deviation) [percentage change in wound area]	-39.2 (38.0)	-46.6 (38.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care, NLFU and Standard of Care
	Comments	The study was powered to detect a difference in the change in wound area of 20% between the two arms with a two sided significance level and power of 90%. A standard deviation of 17.5% came from published literature. A minimum of 17 patients in each arm was required.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.565
	Comments	ANCOVA was used to analyse differences between the NLFU+SOC and SOC arms of the primary endpoint, percentage change in wound area from baseline (week 5) to final visit (week 13). Patients' baseline (week 5) wound area was used as the covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-7.4
	Confidence Interval	(2-Sided) 95%; -33.4 to 18.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change in Overall Health Related Quality of Life (HRQoL) From Week 1 (Start) and Week 13 (Exit)
Description	On the first and final visit participants were invited to complete a Cardiff Wound Impact Schedule (CWIS) a validated questionnaire designed to measure the impact of chronic wounds on patient health-related quality of life (HRQoL). The overall HRQoL question asks patients to rate their overall quality of life over the past week by circling a number between 0 and 10. Low scores indicate poor quality of life, and high score indicate good quality of life. Change in HRQoL was calculated by subtracting week 1 values from week 13 values. CWIS has been validated in the following paper: Price and Harding (2004) The Cardiff Wound Impact Schedule: the development of a condition specific questionnaire to assess health-related quality of life in patients with chronic wounds. International Wound Journal 1(1):10-17
Time Frame	Week 1 (start) and week 13 (exit)

Outcome Measure Data

Analysis Population Description

All patients were analysed by ITT

Arm/Group Title	Standard of Care	NLFU and Standard of Care
Arm/Group Description	Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.	Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
Measure Participants	19	17
Median (Inter-Quartile Range) [units on a scale]	0	-1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care, NLFU and Standard of Care
	Comments	ANCOVA was used for change in HRQoL from week 1 to week 13 (with week 1 HRQoL score as the covariate).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.490
	Comments
	Method	ANCOVA
	Comments

3. Secondary Outcome

Title	Change in Ulcer Pain Between Week 5 (Randomisation) and Week 13 (Exit)
Description	Pain was scored by each patient on a visual analogue score (VAS) from 0 to 100. A VAS score of 0 indicated no pain whilst a VAS score of 100 indicated worst possible pain. Change in pain scores were calculated by subtracting week 5 values from week 13 values.
Time Frame	Weeks 5 to 13

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	NLFU and Standard of Care
Arm/Group Description	Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.	Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
Measure Participants	19	17
Mean (Standard Deviation) [scores on a scale]	-5.27 (14.84)	-14.35 (14.85)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care, NLFU and Standard of Care
	Comments	ANCOVA was used for change in pain score (VAS) from week 5 to week 13 (covariate was baseline pain score).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.078
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-9.08
	Confidence Interval	(2-Sided) 95%; -19.23 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Incidence of Wound Infection
Description	Median number of wound infections per patient (as demonstrated by clinical symptoms) from beginning of treatment (week 5) and end of treatment (week 13).
Time Frame	Weeks 5 to 13

Outcome Measure Data

Analysis Population Description

All patients included; ITT.

Arm/Group Title	Standard of Care	NLFU and Standard of Care
Arm/Group Description	Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.	Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
Measure Participants	19	17
Median (Inter-Quartile Range) [Number of infections per patient]	2	2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care, NLFU and Standard of Care
	Comments	Change in number of infections were not normally distributed and differences between the arms were tested using the non-parametric Mann-Whitney U test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.346
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Secondary Outcome

Title	Number of Non-serious Adverse Events in Each Group
Description	Adverse events (AEs) were defined as any undesirable clinical occurrence in a subject whether it is thought to be related to the investigational device or not.
Time Frame	Week 5 to 13

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	NLFU and Standard of Care
Arm/Group Description	Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.	Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
Measure Participants	19	17
Number [Number of non-serious AEs]	70	59

6. Primary Outcome

Title	Actual Change in Wound Area
Description	Wound area is measured weekly using a digital wound imaging device. The wound boundary is digitally traced by a blinded assessor. Percentage and actual change in wound area between start of treatment (week 5) and end of treatment (week 13) is evaluated.
Time Frame	Week 5 to 13

Outcome Measure Data

Analysis Population Description

As previous

Arm/Group Title	Standard of Care	NLFU and Standard of Care
Arm/Group Description	Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.	Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
Measure Participants	19	17
Mean (Standard Deviation) [cm2]	-5.3 (5.5)	-6.2 (5.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care, NLFU and Standard of Care
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.618
	Comments
	Method	ANCOVA
	Comments	Patients' baseline (week 5) wound area was used as the covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.9
	Confidence Interval	(2-Sided) 95%; -4.7 to 2.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Wound Recurrence Rate
Description	Patients whose wound has healed (defined as 100% epithelialisation with no scab present) before or at the end of treatment will be asked 90 days after date of healing if their wound has remained closed.
Time Frame	90 days after time of healing

Outcome Measure Data

Analysis Population Description

Three patients healed during the study period (one NLFU+SOC patient healed after 7 weeks and one after 8 weeks of NLFU+SOC treatment, and one patient who received standard care alone healed after 4 weeks). All three of these patients remained healed 90 days after the end of their study treatment.

Arm/Group Title	Standard of Care	NLFU and Standard of Care
Arm/Group Description	Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.	Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
Measure Participants	1	2
Number [Number of wounds remained healed]	1	2

Adverse Events

Time Frame	Study period of 13 weeks
Adverse Event Reporting Description	Any undesirable clinical occurrence in a subject whether it is thought to be related to the NLFU or not. All subjects experiencing AEs were monitored until symptoms subside or until there is a satisfactory explanation for the changes observed. The nature of venous leg ulcers meant that AEs were common in both the SOC and NLFU groups
Arm/Group Title	Standard of Care		NLFU and Standard of Care
Arm/Group Description	Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.		Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
All Cause Mortality
	Standard of Care		NLFU and Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard of Care		NLFU and Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Standard of Care		NLFU and Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/19 (100%)		15/17 (88.2%)
General disorders
All adverse events	19/19 (100%)		15/17 (88.2%)

Limitations/Caveats

Difference in treatment frequency between the groups which could potentially bias results. Standard deviation proved to be larger than estimated from the available literature which resulted in the study having reduced statistical power.

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.