Post Thrombotic Syndrome
Conditions
Brief summary
The use of ActiveCare+S.F.T 3rd generation (an Intermittent Pneumatic Compression Device) will improve quality of life in patients suffering from Post Thrombotic Syndrome compared to compression stockings which is the current gold standard of care.
Interventions
DEVICEActiveCare+S.F.T 3rd generation
Intermittent Pneumatic Compression Device
Sponsors
Hadassah Medical Organization
Study design
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients who have developed post Thrombotic leg symptoms after a deep vein thrombosis event.
Exclusion criteria
* admitted patients * Patients who suffer from peripheral artery disease. * Patients with an acute deep vein thrombosis. * s/p leg skin transplant * Patients with an active leg infection * Patients who aren't capable of operating the device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life (Veins-QOL) | 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Villalta Scale | 1 month | The scale consists of five patient-rated venous symptoms (pain, cramps, heaviness, paresthesia, pruritus) and six clinician-rated physical signs (pretibial edema, skin induration, hyperpigmentation,pain during calf compression, venous ectasia, redness),which are each rated on a four-point scale (0 = none,1 = mild, 2 = moderate, 3 = severe). Points are summed to produce a total score (range: 0-33). Subjects are classified as having Post Thrombotic Syndrome if the score is 5 or more, or if a venous ulcer is present, in a leg with previous DVT. |
Countries
Israel
Contacts
Primary ContactGalia Spectre, M.D
Backup ContactHadas Lemberg, PhD
Outcome results
None listed