Trial Outcomes & Findings for Mild Compression Sock for Control of Lower Extremity Edema in Individuals With Diabetes (NCT NCT01529385)

NCT ID: NCT01529385

Last Updated: 2016-06-22

Results Overview

Cutaneous water content was measured non-invasively by tissue dielectric constant (MoistureMeter) at a single location: 2 inches distal and 2 inches lateral to the fibular head.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: change from baseline after 4 weeks of sock usage
• Results posted on: 2016-06-22

Participant Flow

Participant milestones

Measure	Mild Compression Diabetic Sock Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities. mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks	Standard Diabetic Sock A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg. Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks
Overall Study STARTED	40	40
Overall Study Received Intervention	39	40
Overall Study COMPLETED	38	39
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Mild Compression Diabetic Sock Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities. mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks	Standard Diabetic Sock A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg. Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

Mild Compression Sock for Control of Lower Extremity Edema in Individuals With Diabetes

Baseline characteristics by cohort

Measure	Mild Compression Diabetic Sock n=38 Participants Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities. mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks	Standard Diabetic Sock n=39 Participants A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg. Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks	Total n=77 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 13 • n=5 Participants	64 years STANDARD_DEVIATION 13 • n=7 Participants	64 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 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	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	26 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants	39 participants n=7 Participants	77 participants n=5 Participants
Body Mass Index	34.3 kg/m^2 STANDARD_DEVIATION 6.3 • n=5 Participants	35.6 kg/m^2 STANDARD_DEVIATION 7.4 • n=7 Participants	35.0 kg/m^2 STANDARD_DEVIATION 6.9 • n=5 Participants

PRIMARY outcome

Timeframe: change from baseline after 4 weeks of sock usage

Cutaneous water content was measured non-invasively by tissue dielectric constant (MoistureMeter) at a single location: 2 inches distal and 2 inches lateral to the fibular head.

Outcome measures

Measure	Mild Compression Diabetic Sock n=38 Participants Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities. mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks	Standard Diabetic Sock n=39 Participants A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg. Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks
Cutaneous Water Content change after 1 week	-1.1 percentage change in dielectric constant Interval -3.4 to 1.2	-.82 percentage change in dielectric constant Interval -2.9 to 1.2
Cutaneous Water Content change after 2 weeks	-0.99 percentage change in dielectric constant Interval -3.2 to 1.2	-2.1 percentage change in dielectric constant Interval -4.6 to 0.4
Cutaneous Water Content change after 3 weeks	-0.23 percentage change in dielectric constant Interval -2.4 to 2.0	-1.7 percentage change in dielectric constant Interval -4.0 to 0.57
Cutaneous Water Content change after 4 weeks	-.16 percentage change in dielectric constant Interval -2.2 to 1.8	-1.6 percentage change in dielectric constant Interval -3.7 to 0.46

PRIMARY outcome

Timeframe: change from baseline after 4 weeks of sock usage

The circumference of calf was measured by a tape measure.

Outcome measures

Measure	Mild Compression Diabetic Sock n=38 Participants Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities. mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks	Standard Diabetic Sock n=39 Participants A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg. Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks
Calf Edema change after 1 week	-0.48 cm Interval -1.2 to 0.2	-0.73 cm Interval -1.7 to 0.24
Calf Edema change after 2 weeks	-0.89 cm Interval -1.7 to -0.09	-0.82 cm Interval -1.9 to 0.21
Calf Edema change after 3 weeks	-0.75 cm Interval -1.6 to 0.14	-0.85 cm Interval -1.9 to 0.2
Calf Edema change after 4 weeks	-0.95 cm Interval -1.8 to -0.07	-.74 cm Interval -1.8 to 0.3

PRIMARY outcome

Timeframe: change from baseline after 4 weeks of sock usage

The circumference of ankle was measured by a tape measure.

Outcome measures

Measure	Mild Compression Diabetic Sock n=38 Participants Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities. mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks	Standard Diabetic Sock n=39 Participants A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg. Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks
Ankle Edema change after 1 week	-0.42 cm Interval -1.02 to 0.19	-0.15 cm Interval -0.57 to 0.27
Ankle Edema change after 2 weeks	-0.68 cm Interval -1.1 to -0.22	-0.28 cm Interval -0.8 to 0.24
Ankle Edema change after 3 weeks	-0.85 cm Interval -1.4 to -0.31	-0.30 cm Interval -0.87 to 0.27
Ankle Edema change after 4 weeks	-.78 cm Interval -1.4 to -0.019	-0.34 cm Interval -1.0 to 0.36

PRIMARY outcome

Timeframe: change from baseline after 4 weeks of sock usage

ratio of systolic blood pressure of toe relative to systolic blood pressure of arm

Outcome measures

Measure	Mild Compression Diabetic Sock n=38 Participants Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities. mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks	Standard Diabetic Sock n=39 Participants A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg. Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks
Toe Brachial Index change after 1 week	-0.02 unit-less ratio data Interval -0.2 to 0.06	0.05 unit-less ratio data Interval -0.03 to 0.12
Toe Brachial Index change after 2 weeks	0.00 unit-less ratio data Interval -0.06 to 0.06	0.07 unit-less ratio data Interval 0.008 to 0.14
Toe Brachial Index change after 3 weeks	-0.01 unit-less ratio data Interval -0.09 to 0.08	0.05 unit-less ratio data Interval -0.03 to 0.13
Toe Brachial Index change after 4 weeks	-0.003 unit-less ratio data Interval -0.08 to 0.07	0.06 unit-less ratio data Interval -0.01 to 0.13

PRIMARY outcome

Timeframe: change from baseline after 4 weeks of sock usage

ratio of systolic blood pressure of ankle relative to systolic blood pressure of arm

Outcome measures

Measure	Mild Compression Diabetic Sock n=38 Participants Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities. mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks	Standard Diabetic Sock n=39 Participants A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg. Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks
Ankle Brachial Index change after 1 week	0.01 unit-less ratio data Interval -0.04 to 0.06	0.03 unit-less ratio data Interval -0.02 to 0.08
Ankle Brachial Index change after 2 weeks	0.01 unit-less ratio data Interval -0.05 to 0.07	0.05 unit-less ratio data Interval -0.01 to 0.1
Ankle Brachial Index change after 3 weeks	-0.01 unit-less ratio data Interval -0.07 to 0.05	0.03 unit-less ratio data Interval -0.01 to 0.08
Ankle Brachial Index change after 4 weeks	0.01 unit-less ratio data Interval -0.06 to 0.07	0.01 unit-less ratio data Interval -0.05 to 0.07

PRIMARY outcome

Timeframe: change from baseline after 4 weeks of sock usage

The circumference of the foot was measured by a tape measure.

Outcome measures

Measure	Mild Compression Diabetic Sock n=38 Participants Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities. mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks	Standard Diabetic Sock n=39 Participants A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg. Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks
Foot Edema change after 1 week	-0.1 cm Interval -0.6 to 0.3	-0.003 cm Interval -1.02 to 1.01
Foot Edema change after 2 weeks	-0.1 cm Interval -0.5 to 0.4	-0.19 cm Interval -1.17 to 0.79
Foot Edema change after 3 weeks	-0.2 cm Interval -0.7 to 0.3	-0.36 cm Interval -1.5 to 0.75
Foot Edema change after 4 weeks	-0.4 cm Interval -0.9 to 0.1	-0.24 cm Interval -1.3 to 0.85

PRIMARY outcome

Timeframe: change from baseline after 4 weeks of sock usage

microcirculation as measured by skin perfusion pressure

Outcome measures

Measure	Mild Compression Diabetic Sock n=38 Participants Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities. mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks	Standard Diabetic Sock n=39 Participants A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg. Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks
Microcirculation for Medial Calf change after 1 week	5.9 mmHg Interval -1.2 to 13.0	1.9 mmHg Interval -5.3 to 9.0
Microcirculation for Medial Calf change after 2 weeks	7.3 mmHg Interval -0.2 to 14.8	3.6 mmHg Interval -5.7 to 12.9
Microcirculation for Medial Calf change after 3 weeks	6.5 mmHg Interval -1.3 to 14.4	-0.71 mmHg Interval -7.4 to 6.0
Microcirculation for Medial Calf change after 4 weeks	4.8 mmHg Interval -3.1 to 12.8	2.3 mmHg Interval -7.1 to 11.8

PRIMARY outcome

Timeframe: change from baseline after 4 weeks of sock usage

microcirculation as measured by skin perfusion pressure

Outcome measures

Measure	Mild Compression Diabetic Sock n=38 Participants Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities. mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks	Standard Diabetic Sock n=39 Participants A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg. Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks
Microcirculation for Lateral Calf change after 1 week	4.4 mmHg Interval -1.9 to 10.8	2.6 mmHg Interval -1.5 to 6.7
Microcirculation for Lateral Calf change after 2 weeks	4.8 mmHg Interval -5.7 to 15.3	3.5 mmHg Interval -0.36 to 7.4
Microcirculation for Lateral Calf change after 3 weeks	7.4 mmHg Interval -2.4 to 17.3	0.23 mmHg Interval -4.5 to 5.0
Microcirculation for Lateral Calf change after 4 weeks	4.4 mmHg Interval -5.7 to 14.4	-1.1 mmHg Interval -6.3 to 4.0

PRIMARY outcome

Timeframe: change from baseline after 4 weeks of sock usage

microcirculation as measured by skin perfusion pressure

Outcome measures

Measure	Mild Compression Diabetic Sock n=38 Participants Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities. mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks	Standard Diabetic Sock n=39 Participants A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg. Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks
Microcirculation for Dorsum of Foot change after 2 weeks	3.4 mmHg Interval -4.0 to 10.7	0.26 mmHg Interval -7.0 to 7.6
Microcirculation for Dorsum of Foot change after 1 week	-1.7 mmHg Interval -8.4 to 5.0	1.8 mmHg Interval -5.5 to 9.0
Microcirculation for Dorsum of Foot change after 3 weeks	2.6 mmHg Interval -6.4 to 11.6	0.03 mmHg Interval -8.1 to 8.2
Microcirculation for Dorsum of Foot change after 4 weeks	0.13 mmHg Interval -7.5 to 7.8	3.9 mmHg Interval -4.2 to 11.9

SECONDARY outcome

Timeframe: baseline and after four weeks of wearing the socks

Population: physical activity measurements were only made for a sub-sample of the study's complete sample

Physical activity monitors will be used to assess physical activity patters of participants for 48 hours prior to initiating sock usage and for 48 hours after the participants have worn the socks for four weeks.

Outcome measures

Measure	Mild Compression Diabetic Sock n=13 Participants Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities. mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks	Standard Diabetic Sock n=14 Participants A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg. Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks
Physical Activity Level 48hr step count at baseline	16781.8 steps Standard Deviation 14474.6	16984.9 steps Standard Deviation 8559.8
Physical Activity Level 48hr step count after 4 weeks	18056.5 steps Standard Deviation 7360.9	15701.0 steps Standard Deviation 6749.7

Adverse Events

Mild Compression Diabetic Sock

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Standard Diabetic Sock

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Mild Compression Diabetic Sock n=38 participants at risk Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities. mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks	Standard Diabetic Sock n=39 participants at risk A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg. Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks
Infections and infestations spine infection C2-C5	2.6% 1/38 • Number of events 1	0.00% 0/39
Vascular disorders excessive fluid retention	2.6% 1/38 • Number of events 1	0.00% 0/39
Vascular disorders fluid retention and hypertension	0.00% 0/38	2.6% 1/39 • Number of events 1

Other adverse events

Measure	Mild Compression Diabetic Sock n=38 participants at risk Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities. mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks	Standard Diabetic Sock n=39 participants at risk A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg. Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks
Injury, poisoning and procedural complications blister on toe	0.00% 0/38	2.6% 1/39 • Number of events 1
Musculoskeletal and connective tissue disorders fall induced knee pain	0.00% 0/38	2.6% 1/39 • Number of events 1
Nervous system disorders lower extremity numbness	0.00% 0/38	2.6% 1/39 • Number of events 1
General disorders cold	0.00% 0/38	2.6% 1/39 • Number of events 1
Infections and infestations shingles	0.00% 0/38	2.6% 1/39 • Number of events 1
Skin and subcutaneous tissue disorders pruritic lesions	0.00% 0/38	2.6% 1/39 • Number of events 1
Musculoskeletal and connective tissue disorders cramping in feet	2.6% 1/38 • Number of events 1	0.00% 0/39
Skin and subcutaneous tissue disorders skin irritation	5.3% 2/38 • Number of events 2	0.00% 0/39
Musculoskeletal and connective tissue disorders cramping in calf	2.6% 1/38 • Number of events 1	0.00% 0/39

Additional Information

Ryan Crews, Clinical Scientist

Center for Lower Extremity Ambulatory Research

Phone: 847-578-8437

Email: ryan.crews@rosalindfranklin.edu

Results disclosure agreements

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