Mild to Moderate Edema of Diabetic Legs Clinical Trial
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
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | September 2014 |
| Est. primary completion date | September 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| United States | Rosalind Franklin University Health System | North Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Rosalind Franklin University of Medicine and Science | Madigan Army Medical Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | lower extremity edema | The circumference of the foot, ankle and calf will be measured by a tape measurer. Cutaneous fluid will be measured non-invasively by a MoistureMeter. | change from baseline after 1, 2, 3, and 4 weeks of sock usage | No |
| Primary | lower extremity vascular status | The ankle-brachial index, toe-brachial index, skin perfusion pressure and pulse volume recordings will be measured. | change from baseline after 1,2,3, and 4 weeks of sock usage | Yes |
| Secondary | 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. | baseline and after four weeks of wearing the socks | No |