EdemaNCT01529385
Mild Compression Sock for Control of Lower Extremity Edema in Individuals With Diabetes
A study testing mild compression diabetic sock and Standard diabetic sock in people with Edema, run by Rosalind Franklin University of Medicine and Science at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edema
- What is being tested?
- mild compression diabetic sock and Standard diabetic sock
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rosalind Franklin University Health System
North Chicago, Illinois, 60064
About this study
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.
Read the 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.
- Conditions
- Edema
- Being tested
- mild compression diabetic sock, Standard diabetic sock
- Keywords
- swollen leg, diabetes, compression stockings, edema
- Medical subject headings
- Edema, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mild compression diabetic sockDevice
A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks
Standard diabetic sockDevice
A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Mild Compression Diabetic Sock | Experimental | Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities. Receives: Device: mild compression diabetic sock |
| Standard Diabetic Sock | Other | A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg. Receives: Device: Standard diabetic sock |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline after 4 weeks of sock usage
Calf Edema
The circumference of calf was measured by a tape measure.
Measured: change from baseline after 4 weeks of sock usage
Ankle Edema
The circumference of ankle was measured by a tape measure.
Measured: change from baseline after 4 weeks of sock usage
Toe Brachial Index
ratio of systolic blood pressure of toe relative to systolic blood pressure of arm
Measured: change from baseline after 4 weeks of sock usage
Ankle Brachial Index
ratio of systolic blood pressure of ankle relative to systolic blood pressure of arm
Measured: change from baseline after 4 weeks of sock usage
Foot Edema
The circumference of the foot was measured by a tape measure.
Measured: change from baseline after 4 weeks of sock usage
Microcirculation for Medial Calf
microcirculation as measured by skin perfusion pressure
Measured: change from baseline after 4 weeks of sock usage
Microcirculation for Lateral Calf
microcirculation as measured by skin perfusion pressure
Measured: change from baseline after 4 weeks of sock usage
Microcirculation for Dorsum of Foot
microcirculation as measured by skin perfusion pressure
Measured: change from baseline after 4 weeks of sock usage
Secondary outcomes (1)
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.
Measured: baseline and after four weeks of wearing the socks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rosalind Franklin University of Medicine and Science
- Sponsor type
- University, hospital or other
- Collaborators
- Madigan Army Medical Center
- Responsible party
- Principal investigator, Dr. Stephanie Wu, DPM, MS, Rosalind Franklin University of Medicine and Science
- Investigators
- Stephanie Wu, DPM, MS, Principal investigator, Rosalind Franklin University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529385
- Sponsor's protocol ID
- ORT 112
- Status last verified
- May 2016
- First submitted
- 3 Feb 2012
- Last updated
- 22 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01529385
- Acronym / sponsor ID
- ORT 112
- Conditions
- Edema
- Keywords
- swollen leg, diabetes, compression stockings, edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Rosalind Franklin University of Medicine and ScienceUniversity, hospital or other
- Collaborators
- Madigan Army Medical Center
- Study start
- Feb 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Posted 22 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild Compression Diabetic Sock | Experimental | Device: mild compression diabetic sockDiabetic socks that provide 18-25mm Hg of pressure to the lower extremities. |
| Standard Diabetic Sock | Other | Device: Standard diabetic sockA standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mild compression diabetic sockA diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks | Device | Mild Compression Diabetic Sock |
| Standard diabetic sockA diabetic sock that is not designed to provide compression is to be worn everyday for four weeks | Device | Standard Diabetic Sock |
Primary outcome
Cutaneous Water Content
Time frame: 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
Time frame: change from baseline after 4 weeks of sock usage
The circumference of calf was measured by a tape measure.
Ankle Edema
Time frame: change from baseline after 4 weeks of sock usage
The circumference of ankle was measured by a tape measure.
Toe Brachial Index
Time frame: 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
Time frame: 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
Time frame: change from baseline after 4 weeks of sock usage
The circumference of the foot was measured by a tape measure.
Microcirculation for Medial Calf
Time frame: change from baseline after 4 weeks of sock usage
microcirculation as measured by skin perfusion pressure
Microcirculation for Lateral Calf
Time frame: change from baseline after 4 weeks of sock usage
microcirculation as measured by skin perfusion pressure
Microcirculation for Dorsum of Foot
Time frame: change from baseline after 4 weeks of sock usage
microcirculation as measured by skin perfusion pressure
1 secondary outcome
Physical Activity Level
Time frame: baseline and after four weeks of wearing the socks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Wu, DPM, MS principal investigator
Rosalind Franklin University of Medicine and Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mild compression diabetic sock and Standard diabetic sock in people with Edema, run by Rosalind Franklin University of Medicine and Science at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cutaneous Water Content (time frame: change from baseline after 4 weeks of sock usage). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2016.