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

Primary Purpose

Edema

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

mild compression diabetic sock

Standard diabetic sock

About this trial

This is an interventional supportive care trial for Edema focused on measuring swollen leg, diabetes, compression stockings, edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Rosalind Franklin University Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Mild Compression Diabetic Sock

Standard Diabetic Sock

Arm Description

Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.

A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.

Outcomes

Primary Outcome Measures

Cutaneous Water Content

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

The circumference of calf was measured by a tape measure.

Ankle Edema

The circumference of ankle was measured by a tape measure.

Toe Brachial Index

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

Ankle Brachial Index

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

Foot Edema

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

Microcirculation for Medial Calf

microcirculation as measured by skin perfusion pressure

Microcirculation for Lateral Calf

microcirculation as measured by skin perfusion pressure

Microcirculation for Dorsum of Foot

microcirculation as measured by skin perfusion pressure

Secondary Outcome Measures

Physical Activity Level

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.

Full Information

NCT ID

NCT01529385

First Posted

February 3, 2012

Last Updated

May 13, 2016

Sponsor

Rosalind Franklin University of Medicine and Science

Collaborators

Madigan Army Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01529385

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rosalind Franklin University of Medicine and Science

Collaborators

Madigan Army Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Edema

Keywords

swollen leg, diabetes, compression stockings, edema

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mild Compression Diabetic Sock

Arm Type

Experimental

Arm Description

Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.

Arm Title

Standard Diabetic Sock

Arm Type

Other

Arm Description

A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.

Intervention Type

Device

Intervention Name(s)

mild compression diabetic sock

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Standard diabetic sock

Intervention Description

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

Primary Outcome Measure Information:

Title

Cutaneous Water Content

Description

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.

Time Frame