Trial Outcomes & Findings for Metatarsal Phalangeal Joint Deformity Progression - R01 (NCT NCT02616263)

NCT ID: NCT02616263

Last Updated: 2024-12-02

Results Overview

The angle between the 2nd metatarsal and the proximal phalanx will be measured at baseline and again at the 3-years

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: Three years
• Results posted on: 2024-12-02

Participant Flow

Participant milestones

Measure	Foot Intervention The intervention is a progressive, home based exercise program aimed to increase ankle and foot plantarflexion muscle strength, increase ankle dorsiflexion and toe flexion range of motion, and to retrain individuals to dorsiflex the ankle while keeping the toes in a neutral position. A trained physical therapist with experience working with older adults with diabetes and foot specific complications will monitor and progress the exercise program assuring participant safety and maximizing exercise benefit. Foot exercise	Shoulder Intervention Participants will be trained in a progressive home exercise program that includes passive stretching of end range shoulder flexion and external rotation and a tailored dose of active shoulder motion. Shoulder exercise
Baseline to 6 Month (Intervention Phase) STARTED	29	31
Baseline to 6 Month (Intervention Phase) COMPLETED	28	28
Baseline to 6 Month (Intervention Phase) NOT COMPLETED	1	3
6 Month to 1.5 Year STARTED	28	28
6 Month to 1.5 Year COMPLETED	26	25
6 Month to 1.5 Year NOT COMPLETED	2	3
1.5 Year to 3+ Year Follow up STARTED	26	25
1.5 Year to 3+ Year Follow up COMPLETED	22	23
1.5 Year to 3+ Year Follow up NOT COMPLETED	4	2

Reasons for withdrawal

Measure	Foot Intervention The intervention is a progressive, home based exercise program aimed to increase ankle and foot plantarflexion muscle strength, increase ankle dorsiflexion and toe flexion range of motion, and to retrain individuals to dorsiflex the ankle while keeping the toes in a neutral position. A trained physical therapist with experience working with older adults with diabetes and foot specific complications will monitor and progress the exercise program assuring participant safety and maximizing exercise benefit. Foot exercise	Shoulder Intervention Participants will be trained in a progressive home exercise program that includes passive stretching of end range shoulder flexion and external rotation and a tailored dose of active shoulder motion. Shoulder exercise
Baseline to 6 Month (Intervention Phase) Withdrawal by Subject	0	3
Baseline to 6 Month (Intervention Phase) Lost to Follow-up	1	0
6 Month to 1.5 Year Death	1	0
6 Month to 1.5 Year Lost to Follow-up	0	2
6 Month to 1.5 Year Withdrawal by Subject	1	1
1.5 Year to 3+ Year Follow up Withdrawal by Subject	4	2

Baseline Characteristics

Metatarsal Phalangeal Joint Deformity Progression - R01

Baseline characteristics by cohort

Measure	Foot Intervention n=29 Participants The intervention is a progressive, home based exercise program aimed to increase ankle and foot plantarflexion muscle strength, increase ankle dorsiflexion and toe flexion range of motion, and to retrain individuals to dorsiflex the ankle while keeping the toes in a neutral position. A trained physical therapist with experience working with older adults with diabetes and foot specific complications will monitor and progress the exercise program assuring participant safety and maximizing exercise benefit. Foot exercise	Shoulder Intervention n=31 Participants Participants will be trained in a progressive home exercise program that includes passive stretching of end range shoulder flexion and external rotation and a tailored dose of active shoulder motion. Shoulder exercise	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Age, Continuous	67.48 years STANDARD_DEVIATION 8.05 • n=5 Participants	66.55 years STANDARD_DEVIATION 4.14 • n=7 Participants	67 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	19 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	26 Participants n=5 Participants	27 Participants n=7 Participants	53 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or not reported	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	31 participants n=7 Participants	60 participants n=5 Participants
Foot Joint Deformity 2nd Metatarsophalangeal Joint Hyperextension	54.7 Degrees STANDARD_DEVIATION 12.3 • n=5 Participants	51.4 Degrees STANDARD_DEVIATION 13.3 • n=7 Participants	53.0 Degrees STANDARD_DEVIATION 12.8 • n=5 Participants
Foot Joint Deformity Calcaneal Pitch	21.5 Degrees STANDARD_DEVIATION 6.6 • n=5 Participants	18.5 Degrees STANDARD_DEVIATION 5.3 • n=7 Participants	20.0 Degrees STANDARD_DEVIATION 6.1 • n=5 Participants

PRIMARY outcome

Timeframe: Three years

Population: 23 participants in each group completed 3 year follow up testing (average follow up time was 3.6 yrs due to COVID pause in human research testing) to assess the effect of the foot intervention on metatarsophalangeal joint extension alignment.

The angle between the 2nd metatarsal and the proximal phalanx will be measured at baseline and again at the 3-years

Outcome measures

Measure	Foot Intervention n=23 Participants The intervention is a progressive, home based exercise program aimed to increase ankle and foot plantarflexion muscle strength, increase ankle dorsiflexion and toe flexion range of motion, and to retrain individuals to dorsiflex the ankle while keeping the toes in a neutral position. A trained physical therapist with experience working with older adults with diabetes and foot specific complications will monitor and progress the exercise program assuring participant safety and maximizing exercise benefit. Foot exercise	Shoulder Intervention n=23 Participants Participants will be trained in a progressive home exercise program that includes passive stretching of end range shoulder flexion and external rotation and a tailored dose of active shoulder motion. Shoulder exercise
Change in Metatarsal Phalangeal Joint Angle (Degrees) in People With Diabetes From Baseline and at a 3-year Period	0.8 degrees Standard Deviation 9.3	-0.1 degrees Standard Deviation 8.2

Adverse Events

Foot Intervention

Serious events: 0 serious events

Other events: 12 other events

Deaths: 1 deaths

Shoulder Intervention

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Foot Intervention n=29 participants at risk The intervention is a progressive, home based exercise program aimed to increase ankle and foot plantarflexion muscle strength, increase ankle dorsiflexion and toe flexion range of motion, and to retrain individuals to dorsiflex the ankle while keeping the toes in a neutral position. A trained physical therapist with experience working with older adults with diabetes and foot specific complications will monitor and progress the exercise program assuring participant safety and maximizing exercise benefit. Foot exercise	Shoulder Intervention n=31 participants at risk Participants will be trained in a progressive home exercise program that includes passive stretching of end range shoulder flexion and external rotation and a tailored dose of active shoulder motion. Shoulder exercise
General disorders Falls	17.2% 5/29 • Number of events 6 • Through study completion, on average 3.6 years Adverse event were collected systematically through standardized questions answered during 3 month follow up phone calls or during study visits (e.g. falls, skin breakdown, foot pain, shoulder pain, changes in medical conditions, or new medical conditions). Unexpected adverse events were recorded when information was volunteered or discovered (e.g. failure to answer follow up phone calls resulted in a search of the social security web site to identify of participants were deceased).	19.4% 6/31 • Number of events 7 • Through study completion, on average 3.6 years Adverse event were collected systematically through standardized questions answered during 3 month follow up phone calls or during study visits (e.g. falls, skin breakdown, foot pain, shoulder pain, changes in medical conditions, or new medical conditions). Unexpected adverse events were recorded when information was volunteered or discovered (e.g. failure to answer follow up phone calls resulted in a search of the social security web site to identify of participants were deceased).
General disorders Pain	0.00% 0/29 • Through study completion, on average 3.6 years Adverse event were collected systematically through standardized questions answered during 3 month follow up phone calls or during study visits (e.g. falls, skin breakdown, foot pain, shoulder pain, changes in medical conditions, or new medical conditions). Unexpected adverse events were recorded when information was volunteered or discovered (e.g. failure to answer follow up phone calls resulted in a search of the social security web site to identify of participants were deceased).	12.9% 4/31 • Number of events 4 • Through study completion, on average 3.6 years Adverse event were collected systematically through standardized questions answered during 3 month follow up phone calls or during study visits (e.g. falls, skin breakdown, foot pain, shoulder pain, changes in medical conditions, or new medical conditions). Unexpected adverse events were recorded when information was volunteered or discovered (e.g. failure to answer follow up phone calls resulted in a search of the social security web site to identify of participants were deceased).
Skin and subcutaneous tissue disorders Foot skin breakdown	24.1% 7/29 • Number of events 12 • Through study completion, on average 3.6 years Adverse event were collected systematically through standardized questions answered during 3 month follow up phone calls or during study visits (e.g. falls, skin breakdown, foot pain, shoulder pain, changes in medical conditions, or new medical conditions). Unexpected adverse events were recorded when information was volunteered or discovered (e.g. failure to answer follow up phone calls resulted in a search of the social security web site to identify of participants were deceased).	29.0% 9/31 • Number of events 17 • Through study completion, on average 3.6 years Adverse event were collected systematically through standardized questions answered during 3 month follow up phone calls or during study visits (e.g. falls, skin breakdown, foot pain, shoulder pain, changes in medical conditions, or new medical conditions). Unexpected adverse events were recorded when information was volunteered or discovered (e.g. failure to answer follow up phone calls resulted in a search of the social security web site to identify of participants were deceased).

Additional Information

Dr. Mary Hastings, Professor

Washington University in St. Louis, School of Medicine, Program in Physical Therapy

Phone: 3142107108

Email: hastingsmk@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place