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

NCT ID: NCT04181580

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-28
• Study Completion Date: 2019-12-13

Brief Summary

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

Detailed Description

Lower and upper extremities of 36 health subjects will be measured be 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.

Conditions

Product Use Issue

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Fit test of made-to-measure garments

Healthy subjects will test maximum 2 compression garments out of 6 garments under investigation

Group Type: OTHER

Made-to-measure compression garment

Intervention Type: DEVICE

Made-to-measure compression garment

Interventions

Made-to-measure compression garment

Made-to-measure compression garment

Intervention Type: DEVICE

Eligibility Criteria

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 Pearl-Index of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices (IUDs), sexual abstinence or vasectomized partner for at least 4 weeks
• Willingness to conduct a urine pregnancy test for all females or potentially childbearing diverse subjects
• Capability and willingness to follow protocol requirements
• Signed informed consent for study participation and data protection regulations
• Body mass index (BMI) >23 kg/m² and ≤ 40 kg/m²

Exclusion Criteria

• Circumference of the largest circumference of the upper leg >80 cm (measured in the upright position)
• Shape distortions
• Diagnosed lymphedema of the upper and/or lower extremities
• Diagnosed lipedema of upper and/or 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
• Circumference of the largest circumference of the upper leg >80 cm (measured in the upright position)
• Shape distortions
• Diagnosed lymphedema of the upper and/or lower extremities
• Diagnosed lipedema of upper and/or 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BSN Medical GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uwe Kröncke

Role: PRINCIPAL_INVESTIGATOR

Bioskin GmbH

Locations

bioskin GmbH

Hamburg, , Germany

Countries

Germany

Other Identifiers

BSN-C2593

Identifier Type: -

Identifier Source: org_study_id