N/A N=80 Randomized Triple-blind Supportive Care

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

Edema

Bottom Line

View on ClinicalTrials.gov: NCT01529385 ↗

Enrolled (actual)

Serious AEs

3.9%

Results posted

Jun 2016

Primary outcome: Primary: Cutaneous Water Content — -1.1; -.82; -0.99; -2.1 percentage change in dielectric constant — p=>0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: mild compression diabetic sock (Device); Standard diabetic sock (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Rosalind Franklin University of Medicine and Science
Primary completion: Sep 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Cutaneous Water Content	-1.1; -.82; -0.99; -2.1; -0.23; -1.7	>0.05
PRIMARY Calf Edema	-0.48; -0.73; -0.89; -0.82; -0.75; -0.85	<0.05 sig
PRIMARY Ankle Edema	-0.42; -0.15; -0.68; -0.28; -0.85; -0.30	<.05 sig
PRIMARY Toe Brachial Index	-0.02; 0.05; 0.00; 0.07; -0.01; 0.05	>0.05
PRIMARY Ankle Brachial Index	0.01; 0.03; 0.01; 0.05; -0.01; 0.03	>0.05
PRIMARY Foot Edema	-0.1; -0.003; -0.1; -0.19; -0.2; -0.36	>0.05
PRIMARY Microcirculation for Medial Calf	5.9; 1.9; 7.3; 3.6; 6.5; -0.71	>0.05
PRIMARY Microcirculation for Lateral Calf	4.4; 2.6; 4.8; 3.5; 7.4; 0.23	>0.05
PRIMARY Microcirculation for Dorsum of Foot	-1.7; 1.8; 3.4; 0.26; 2.6; 0.03	>0.05
SECONDARY Physical Activity Level	16781.8; 16984.9; 18056.5; 15701.0	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01529385). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.