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

Efficacy of a Mild Compression Diabetic Sock Versus A Non- Compression Diabetic Sock in the Control of Lower Extremity Edema in Patients With Diabetes: A Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01529385

Enrollment

Registered

2012-02-08

Start date

2012-02-29

Completion date

2014-09-30

Last updated

2016-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edema

Keywords

swollen leg, diabetes, compression stockings, edema

Brief summary

The purpose of this study is to determine whether a specially designed sock for people with diabetes and swelling in the legs can reduce the swelling, improve blood flow to the legs, and improve physical activity patterns of those individuals by providing mild compression to their legs.

Detailed description

Peripheral arterial disease (PAD) is commonly associated with diabetes. Clinicians are often reluctant to apply compressive stockings to patients with diabetes and swollen legs due to fear of exacerbating the symptoms of PAD. The study sock is a newly formulated sock that offers mild compression (18-25mmHg). The sock is made especially for the diabetic patient who suffers from concomitant lower extremity edema. Eighty patients with diabetes and lower extremity edema will be recruited. Upon ensuring enrollment criteria are met, baseline edema (as measured by circumference of foot, ankle and calf), ankle brachial index (ABI), skin perfusion pressure, and cutaneous fluid level (as measured by MoistureMeter) will be assessed. Subjects will then be provided four pairs of socks. Subjects will be randomized in a 1:1 distribution to receive either the mild compression diabetic socks or a standard diabetic sock. They will return for four weekly follow up visits. Additionally a sub-set of 30 subjects will be monitored for changes in physical activity pre and post sock usage. Physical activity monitors will be used to assess daily physical activity for 48hrs prior to receiving the socks and after wearing the socks for four weeks an additional 48hrs will be monitored.

Interventions

DEVICEmild compression diabetic sock

A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks

DEVICEStandard diabetic sock

A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female with lower extremity edema aged 18 or older with the ability and willingness to provide Informed consent * Patient's ankle-brachial systolic pressure index \> 0.6 and toe-brachial index \> 0.3 * Patient is willing to participate in all procedures and follow up evaluations necessary to complete the study. * Patient has diabetes type 1 or type 2 confirmed by patient's primary care physician.

Exclusion criteria

* Patients with active wound infection, or untreated osteomyelitis, gangrene * Patients with dementia, or impaired cognitive function that would prohibit study compliance * Patients with wide spread malignancy or systemically immuno-compromising disease * Patients who are unable or unwilling to participate in all procedures and follow up evaluations * Patient with deep and/or large ulcers that require copious bandaging and may affect efficacy of socks. Patients with superficial ulcers that only require a light dressing are not excluded. The ulcer, if present, must be superficial and cannot exhibit any clinical signs of infection * Patients with restless leg syndrome, Parkinson's disease, or other disease that will cause involuntary movement during microvascular assessment * Patients with severe edema or calf circumference greater than 24 or 46cm * Patients with severe lymphedema * Patients with edema that in the opinion of the investigator requires higher compression than the 18-25mmHg provided by the compression socks * Patients who are currently wearing compression hose. (Patients who have been prescribed compression hose but have not worn compression stockings for the past 6 months can be included in the study) * Patients unable to walk one hundred feet.

Design outcomes

Primary

Measure	Time frame	Description
Microcirculation for Dorsum of Foot	change from baseline after 4 weeks of sock usage	microcirculation as measured by skin perfusion pressure
Cutaneous Water Content	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.
Calf Edema	change from baseline after 4 weeks of sock usage	The circumference of calf was measured by a tape measure.
Ankle Edema	change from baseline after 4 weeks of sock usage	The circumference of ankle was measured by a tape measure.
Toe Brachial Index	change from baseline after 4 weeks of sock usage	ratio of systolic blood pressure of toe relative to systolic blood pressure of arm
Ankle Brachial Index	change from baseline after 4 weeks of sock usage	ratio of systolic blood pressure of ankle relative to systolic blood pressure of arm
Foot Edema	change from baseline after 4 weeks of sock usage	The circumference of the foot was measured by a tape measure.
Microcirculation for Medial Calf	change from baseline after 4 weeks of sock usage	microcirculation as measured by skin perfusion pressure
Microcirculation for Lateral Calf	change from baseline after 4 weeks of sock usage	microcirculation as measured by skin perfusion pressure

Secondary

Measure	Time frame	Description
Physical Activity Level	baseline and after four weeks of wearing the socks	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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	38
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	39
Total	77

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	2	1

Baseline characteristics

Characteristic	Mild Compression Diabetic Sock	Standard Diabetic Sock	Total
Age, Continuous	66 years STANDARD_DEVIATION 13	64 years STANDARD_DEVIATION 13	64 years STANDARD_DEVIATION 12
Body Mass Index	34.3 kg/m^2 STANDARD_DEVIATION 6.3	35.6 kg/m^2 STANDARD_DEVIATION 7.4	35.0 kg/m^2 STANDARD_DEVIATION 6.9
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Asian	3 Participants	2 Participants	5 Participants
Race (NIH/OMB) Black or African American	15 Participants	10 Participants	25 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) White	19 Participants	26 Participants	45 Participants
Region of Enrollment United States	38 participants	39 participants	77 participants
Sex: Female, Male Female	18 Participants	19 Participants	37 Participants
Sex: Female, Male Male	20 Participants	20 Participants	40 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	4 / 38	6 / 39
serious Total, serious adverse events	2 / 38	1 / 39