NCT05925907

Brief Summary

To report Cold intolerance by the CISS score in medicolegal patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

December 12, 2023

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

December 21, 2023

Status Verified

December 1, 2023

Enrollment Period

20 days

First QC Date

June 13, 2023

Last Update Submit

December 18, 2023

Conditions

Hand Injuries

Keywords

CISS, handsurgery, crush, nerve injury , amputation, coldintolerance

Outcome Measures

Primary Outcomes (1)

  • Validation of a Dutch language translation of standard cold intolerance form

    Test and retest of a Dutch language model of the CISS score

    1 year

Study Arms (2)

Handsurgery patients

patients recruited from trauma handsurgery outpatient clinic in an academic teaching hospital, level 1 trauma unit.

Medicolegal patients

Medicolegal patients that are examined in order to asses their personal injury claim.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Handsurgery patients and medicolegal patients

You may qualify if:

  • \- Adult
  • Traumatic hand injury
  • Sufficient knowledge of the Dutch language (at least level B1)

You may not qualify if:

  • \- Definitive total hand amputation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmuc MC

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

MeSH Terms

Conditions

Hand InjuriesCrisponi syndromePressure Ulcer

Condition Hierarchy (Ancestors)

Wounds and InjuriesSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Reinier Feitz, MD PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Reinier Feitz, MD PhD

CONTACT

0303200556info@handcentrum.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reinier Feitz, MD, PhD, plastic surgeon

Study Record Dates

First Submitted

June 13, 2023

First Posted

June 29, 2023

Study Start

December 12, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2025

Last Updated

December 21, 2023

Record last verified: 2023-12

Locations

NL(1)