Feasibility Study Focusing on Fit of Made-to-measure Compression Garments in Healthy Subjects II

BSN Medical

Status

Completed

Conditions

Product Use Issue

Treatments

Device: Made-to-measure compression garment

Study type

Interventional

Funder types

Industry

Identifiers

NCT04714476

BSN-C2673

Details and patient eligibility

About

Fit of made-to-measure compression garments in healthy subjects will be tested on one day, simulating daily activities.

Full description

Lower extremities of 36 healthy subjects will be measured by trained experts to collect measures for made-to-measure compression garments.

Fit of made-to-measure compression garments, which are not on the market yet, among healthy subjects will be tested on one day, simulating daily activities. Fit will be assessed directly after donning and after a wearing period of maximum 7 hours at the study site by trained experts. Healthy subjects will give back study products at the end of the wearing period. AEs will be documented throughout the study.

Enrollment

36 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Men, women or diverse
Full legal competence
Age between 18 and 70 years
Capability to understand the subject information and to provide conscious informed consent
All female or diverse subjects of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of a Pearl-Index less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices, sexual abstinence or vasectomized partner for at least 4 weeks
Willingness to conduct a urine pregnancy test for all female or diverse subjects of childbearing potential
Capability and willingness to follow protocol requirements
Signed informed consent for study participation and data protection regulations
BMI >23 kg/m² and ≤ 40 kg/m²

Exclusion criteria

Circumference of the largest circumference of the upper leg >90 cm (measured in the upright position)
Shape distortions between the waist and the feet
Diagnosed lymphedema of the lower extremities
Diagnosed lipedema of lower extremities
Diagnosed indication for therapy with flat-knitted compression garments
Alcohol abuse as reported by subject and/ or suspected by investigator
Drug abuse as reported by subject and/ or suspected by investigator
Allergy or sensitivity to one or more components of the investigational devices, as far as reported by the subject
Pregnancy or breastfeeding
Diagnosed peripheral arterial disease
Presence of untreated phlebitis, or septic phlebitis
Diagnosed progressed arterial insufficiency including ischemia
Diagnosed congestive heart failure
Diagnosed clinically relevant hypertension
Diagnosed renal insufficiency or kidney failure
Presence of Untreated or progressing skin infection
Presence of large coagulum in the leg vein
Presence of phlegmasia coerulea dolens
Diagnosed Raynaud's disease
Diagnosed gonarthrosis
Diagnosed ankle arthrosis
Diagnosed rheumatoid arthritis
Presence of exuding dermatoses
Presence of gangrene
Diagnosed malign lymphedema
Diagnosed psoriasis
Diagnosed diabetes mellitus
Diagnosed complex regional pain syndrome (CRPS; Sudeck atrophy)
Diagnosed polyneuropathy
Diagnosed severe impaired skin sensitivity und impaired sensitivity of the extremities, including all sensory malfunctions and diagnosed impaired pain sensitivity
Objections of the investigator to the subject's participation in the trial due to medical reasons or any other reason for which the subject should not participate in the opinion of the investigator
Participation in any clinical investigation with systemic and/or pharmaceutical substances within the last 4 weeks and/or in parallel
Sponsors, manufacturers or CRO staff
Surgery in the test area within the last 4 weeks
Open wounds in the test area