- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04714476
Feasibility Study Focusing on Fit of Made-to-measure Compression Garments in Healthy Subjects II
Explorative, Monocentric, Feasibility Study Focusing on Fit of Innovative, Made-to-measure Compression Garments in Healthy Subjects II
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Schleswig-Holstein
-
Schenefeld, Schleswig-Holstein, Germany, 22869
- proDERM GmbH Institut für Angewandte Dermatologische Forschung
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fit test of made-to-measure garments
Healthy subjects will test made-to-measure compression garments
|
Subjects will wear one of two made-to-measure compression garments: (1) JOBST® Confidence leggins (BT) and (2) JOBST® Confidence Bermuda (ET) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the fit of the investigational device
Time Frame: One day
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kirstin Deuble-Bente, Dr., proDERM GmbH Institut für Angewandte Dermatologische Forschung
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BSN-C2673
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Product Use Issue
-
BSN Medical GmbHCompletedProduct Use IssueGermany
-
Bernard FiorettiCompleted
-
Shanghai Jiao Tong University School of MedicineActive, not recruitingOsteoarthritis, Knee | Sports Physical Therapy | Product Use IssueChina
-
National Institute of Environmental Health Sciences...Completed
-
Morgan State UniversityNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingTobacco Product UseUnited States
-
Christopher BellRecruiting
-
Walter Reed Army Institute of Research (WRAIR)Enrolling by invitationPerformance Enhancing Product UseUnited States
-
U.S. Army Medical Research and Development CommandWalter Reed Army Institute of Research (WRAIR)Enrolling by invitationSleep | Performance Enhancing Product Use
-
McGill UniversityWorld Anti-Doping Agency; International Olympic Committee; Phantom Compass; Digitalmill...UnknownPerformance Enhancing Product Use | Doping in Sport
-
National Institute of Cardiovascular Diseases,...CompletedMedication Errors and Other Product Use Errors and IssuesSlovakia
Clinical Trials on Made-to-measure compression garment
-
BSN Medical GmbHCompletedProduct Use IssueGermany
-
Clalit Health ServicesUniversity of HaifaCompletedColles' Fracture | Distal Radius Fractures | Fracture of Lower End of Radius | Smith's FractureIsrael
-
Hôpital Léon BérardTerminated
-
AHS Cancer Control AlbertaCross Cancer InstituteCompletedBreast Cancer | LymphedemaCanada
-
University Hospital Schleswig-HolsteinCompleted
-
University of Colorado, DenverNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Recruiting
-
University of Colorado, DenverColorado Joint Replacement; mediCompleted
-
Hôpital Raymond PoincaréUnknownHypermobility Type Ehlers-Danlos SyndromeFrance
-
University of CalgaryCompleted
-
Nationwide Children's HospitalCompletedSyncope | Postural Orthostatic Tachycardia Syndrome (POTS)United States