Trial Outcomes & Findings for Scleroderma ARFI Imaging of the Skin (NCT NCT02006420)

NCT ID: NCT02006420

Last Updated: 2019-07-05

Results Overview

Skin stiffness was measured from the forearm and thigh of patients with scleroderma using ultrasound shear wave velocity imaging. Shear wave velocity is measured in meters per second (m/s).

Recruitment status

COMPLETED

Target enrollment

45 participants

Primary outcome timeframe

Cross-sectional study, 1 visit, <1 hr

Results posted on

2019-07-05

Participant Flow

Participant milestones

Participant milestones
Measure	Scleroderma Scleroderma participants could have limited or diffuse scleroderma Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.	Control Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.
Overall Study STARTED	24	21
Overall Study COMPLETED	24	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Scleroderma ARFI Imaging of the Skin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Scleroderma n=24 Participants Ultrasound imaging of forearm and thigh, lasting approximately 5-10 minutes. ARFI-SVI Ultrasound: Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.	Control n=21 Participants Ultrasound imaging of forearm and thigh, lasting approximately 5-10 minutes. ARFI-SVI Ultrasound: Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.	Total n=45 Participants Total of all reporting groups
Age, Continuous	48.7 years STANDARD_DEVIATION 14.6 • n=5 Participants	47.7 years STANDARD_DEVIATION 14.68 • n=7 Participants	48.2 years STANDARD_DEVIATION 14.65 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Cross-sectional study, 1 visit, <1 hr

Skin stiffness was measured from the forearm and thigh of patients with scleroderma using ultrasound shear wave velocity imaging. Shear wave velocity is measured in meters per second (m/s).

Outcome measures

Outcome measures
Measure	Scleroderma n=24 Participants Scleroderma participants could have limited or diffuse scleroderma. Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.	Control n=21 Participants Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.
Mean Skin Stiffness Forearm	2.68 meters per second Standard Deviation 0.82	2.07 meters per second Standard Deviation 0.25
Mean Skin Stiffness Thigh	2.23 meters per second Standard Deviation 0.48	2.27 meters per second Standard Deviation 0.36

SECONDARY outcome

Timeframe: Cross-sectional study, 1 visit, <1 hr

Durometer scoring of skin stiffness in two groups of patients (controls and scleroderma). Durometer measurements are expressed in standardized international durometer units ranging from 0 to 100 where 100 is harder (worse outcome) The Rex Gauge model DD-3 was used. For further reference see Arthritis and Rheumatism (Arthritis Care \& Research) Vol. 55. No. 4, August 15, 2006, pp. 603-609. DOI 10.1002/art.22093.

Outcome measures

Outcome measures
Measure	Scleroderma n=24 Participants Scleroderma participants could have limited or diffuse scleroderma. Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.	Control n=21 Participants Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.
Mean Skin Stiffness as Measured by Durometer Scoring Forearm	30.5 units on a scale Standard Deviation 9.4	19.1 units on a scale Standard Deviation 2.8
Mean Skin Stiffness as Measured by Durometer Scoring Thigh	30.1 units on a scale Standard Deviation 8.5	19.3 units on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: Cross-sectional study, 1 visit, <1 hr

Pearson correlation assesses the linear relationship between Ultrasound skin stiffness measurements and Durometer scoring of skin stiffness. Data was combined for scleroderma and control subjects to assess the relationship and association across a broad range of skin conditions.

Outcome measures

Outcome measures
Measure	Scleroderma n=45 Participants Scleroderma participants could have limited or diffuse scleroderma. Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.	Control Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.
Linear Relationship Between Ultrasound Skin Stiffness and Durometer Forearm	0.45 Correlation coefficient	—
Linear Relationship Between Ultrasound Skin Stiffness and Durometer Thigh	0.40 Correlation coefficient	—

SECONDARY outcome

Timeframe: Cross-sectional study, 1 visit, <1 hr

Mean Landmark scores are on a scale of 0 to 3, 0 = normal and 3 =marked skin hardening.

Outcome measures

Outcome measures
Measure	Scleroderma n=24 Participants Scleroderma participants could have limited or diffuse scleroderma. Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.	Control n=21 Participants Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.
Mean Landmark Scores Forearm	0.6667 units on a scale Interval 0.0 to 2.0	0 units on a scale Interval 0.0 to 0.0
Mean Landmark Scores Thigh	0.58333 units on a scale Interval 0.0 to 2.0	0 units on a scale Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Cross-sectional study, 1 visit, <1 hr

Pearson correlation assesses the linear relationship between ultrasound skin stiffness and subjective skin scoring (Landmark) of skin stiffness in all patients (controls plus scleroderma). Data was combined for scleroderma and control subjects to assess the relationship and association across a broad range of skin conditions.

Outcome measures

Outcome measures
Measure	Scleroderma n=45 Participants Scleroderma participants could have limited or diffuse scleroderma. Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.	Control Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.
Linear Relationship Between Ultrasound Skin Stiffness and Landmark Forearm	.65 correlation coefficient	—
Linear Relationship Between Ultrasound Skin Stiffness and Landmark Thigh	.55 correlation coefficient	—

SECONDARY outcome

Timeframe: Cross-sectional study, 1 visit, <1 hr

Population: Of 24 scleroderma participants, data was not available for 2.

MRSS scores exist on a scale from 0 to 51 based on scores of 0 to 3 measured in 17 locations on the body, where 0 represents overall healthy skin and 51 would be the worst outcome in all 17 locations. MRSS measures are not taken on healthy participants.

Outcome measures

Outcome measures
Measure	Scleroderma n=22 Participants Scleroderma participants could have limited or diffuse scleroderma. Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.	Control Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.
MRSS Scores for Scleroderma Participants.	11.27273 units on a scale Interval 2.0 to 29.0	—

SECONDARY outcome

Timeframe: Cross-sectional study, 1 visit, <1 hr

Population: Data for 2 of 24 participants is not available.

Pearson correlation assesses the linear relationships between ultrasound skin stiffness and subjective skin scoring (MRSS) of skin stiffness. MRSS is the Modified Rodnan Score. Skin thickness is measured by clinical palpation using a 0-3 scale. 0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness with inability to pinch the skin into a fold. Because MRSS measurements were not taken for healthy participants, no correlations are provided for them. Therefore, the correlations are based on a skin stiffness and skin scoring solely for scleroderma participants.

Outcome measures

Outcome measures
Measure	Scleroderma n=22 Participants Scleroderma participants could have limited or diffuse scleroderma. Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.	Control Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.
Linear Relationship Between Ultrasound Skin Stiffness and MRSS Thigh	0.36 correlation coefficient	—
Linear Relationship Between Ultrasound Skin Stiffness and MRSS Forearm	0.53 correlation coefficient	—

Adverse Events

Scleroderma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dinesh Khanna

University of Michigan

Phone: 734-763-7182

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place