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

NCT04714476 | Completed

• 1 other identifier: BSN-C2673
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Product Use Issue

Outcome Measures

Primary Outcomes (1)

• Evaluation of the fit of the investigational device

  Evaluation of the fit of the investigational medical device at the end of a wearing period of approximately 4 - 7 hours, to be worn by healthy subjects once. The fit will be evaluated visually as well as manually by predefined criteria, e.g. fit of the upper hem, fit of the investigational medical device at the body area, fit at the thighs, fit in the knee area, fit at the lower hem. The fit will be evaluated using a Visual Analog Scale VAS-10 (0=very good to 10= worse).

  One day

Study Arms (1)

Fit test of made-to-measure garments

EXPERIMENTAL

Healthy subjects will test made-to-measure compression garments

Device: Made-to-measure compression garment

Interventions

Made-to-measure compression garment DEVICE

Subjects will wear one of two made-to-measure compression garments: (1) JOBST® Confidence leggins (BT) and (2) JOBST® Confidence Bermuda (ET)

Fit test of made-to-measure garments

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BSN Medical GmbH: lead
• proDERM GmbH: collaborator

Study Sites (1)

proDERM GmbH Institut für Angewandte Dermatologische Forschung

Schenefeld, Schleswig-Holstein, 22869, Germany

Location

Study Officials

• Kirstin Deuble-Bente, Dr.

  proDERM GmbH Institut für Angewandte Dermatologische Forschung

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Healthy subjects will test made-to-measure compression garments. No comparator group due to explorative design.

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 19, 2021
• Study Start: February 23, 2021
• Primary Completion: March 12, 2021
• Study Completion: March 12, 2021
• Last Updated: February 5, 2025

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)