CClinicalTrials.gg
TerminatedNCT01486225Updated Aug 8, 2014

Tolerance Study of the Silicone Bands on Medical Compression Stockings

A Phase 4 interventional study of Innothera's brand Stockings and Stockings other than Innothera's brand in Skin Lesions, sponsored by Laboratoires Innothera. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-08.

Sponsored by Laboratoires Innothera · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
3
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to identify the nature of skin lesions that develop on contact with the grip-top bands of medical compression stockings, which are composed mainly of silicone.

Read the detailed description

To identify the nature of lesions the investigator will analyse results of the biopsys, microbiological analyses, dermatological tests.

02

Conditions studied

  • Skin Lesions
03

In context

Lead sponsor

Laboratoires Innothera is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects who notified a health care professional (doctor or pharmacist) of an incident with a grip-top bands compression stocking, regardless of brand and model.
  • Subjects presenting skin lesions caused by the contact with silicone-containing grip-top bands of medical compression stockings (all brands combined).
  • Subjects for whom the incriminated stockings provide class 2 compression or higher.
  • Subjects covered by French national health insurance.
  • Subjects who give their written informed consent and who accept the constraints of the study.

Exclusion criteria

Exclusion Criteria:

  • Known allergy to local anesthetics (lidocaine, etc.).
  • History of anaphylactic shock.
  • Ongoing antihistamine treatment or having taken during the week before inclusion.
  • Patient on ongoing systemic corticosteroids or having taken corticosteroids in the month before inclusion.
  • Patient having used a topical corticosteroid in the area where the patch tests or prick tests will be performed during the week before inclusion.
  • Phototherapy or sun exposure in the 30 days preceding the skin tests (on the back).
  • Patient having concomitantly used compression stockings and a topical corticosteroid on the thighs in the 48 hours preceding lesion onset.
  • List of diseases which will prevent a subject from participating in the study:
  • acquired, infectious or drug-induced congenital immunosuppression (systemic corticosteroid therapy, immunosuppressives, chemotherapy),
  • Congenital bullous disorder (congenital epidermolysis bullosa) or acquired bullous disorder (pemphigus, pemphigoid, dermatitis herpetiformis, linear IgA dermatosis, etc.).
  • Patients with an ongoing or previous history of mental or psychiatric disorder or condition or any other factor interfering with the ability to give informed consent.
  • Any major systemic disease making the conduct of the study or the interpretation of the results difficult.
  • Patients with ongoing or previous history of decompensated heart failure.
  • Chemotherapy or active cancer.
  • Pregnancy.
  • Patients participating in an ongoing clinical trial or in the exclusion period of a previous trial.
  • Persons deprived of their liberty by judicial or administrative decision or persons hospitalized without their consent.
  • Legally protected adults under guardianship.
  • If the patient accepts the biopsy proposed in the study:
  • Patient for whom a skin biopsy is contra-indicated or requiring antibiotic prophylaxis,
  • Anticoagulant taken during the 24 hours before inclusion.
  • Subject with history of allergy to natural or synthetic latex, chlorhexidine, known healing disorder and/or viral diseases transmissible through the blood documented by the preliminary clinical exam.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
3 participants (actual)

Study arms

  • Other
    Innothera's brand Stokings

    Innothera's branded grip-top silicone band stokingc

    Device: Innothera's brand Stockings

  • Other
    Other than Innothera's brand

    Other: Stockings other than Innothera's brand

Interventions

  • DeviceInnothera's brand Stockings

    15 patients having used Innothera branded Stocking

    Also known as: Medical compression stockings

  • OtherStockings other than Innothera's brand

    15 patients having used any other brand than Innothera's brand stockings

    Also known as: Other Names:, Medical compression stockings

06

What researchers measure

Primary outcomes

  1. nature and outcome of skin lesion caused by the silicone from the grip-top band of medical stockings

    Patient will be followed during 5 days from the time that lessions occurs

    Time frame: within 5 days from skin lesion started

07

Study locations

1 site
  • Hôpitaux de Brabois CHU de Nancy
    Nancy, 54500, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01486225
Lead sponsor
Laboratoires Innothera
Responsible party
Sponsor
First posted
Dec 6, 2011
Start date
Nov 2011
Primary completion
Oct 2013
Completion
Oct 2013
Last update
Aug 8, 2014

Study contacts

Annick BARBAUD, MD Professor
principal investigator · Central Hospital, Nancy, France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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