Evaluation of Digit Tip and Split Skin Donor Site Transcr... | NCT05991765

Studies
Evaluation of Digit Tip and Split Skin Donor Site Transcriptome

NCT05991765

Sponsor

University Hospital Schleswig-Holstein

Status

Unknown status

Last Update Posted

Aug 15, 2023Actual

Enrollment

75Actual

Phase

Not provided

Conditions

Digit Tip Wound
Split Skin Donor Site

Interventions

Digit Tip Wound
Split Skin Donor Site Wound

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Actual

Primary Completion Date

Apr 30, 2022Actual

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Aug 7, 2023

First Submission Date that Met QC Criteria

Aug 7, 2023

First Posted Date

Aug 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2023

Last Update Posted Date

Aug 15, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tobias Kisch, Principal Investigator, University Hospital Schleswig-HolsteinPrincipal Investigator

Lead Sponsor

University Hospital Schleswig-HolsteinOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Regrowth of amputated fingertips presents a unique regenerative healing process in mammals, with subcutaneous volume regrowth, restoration of the dactylogram, and suppression of scar formation. In addition, wound healing from split-thickness donor sites shows almost scar-free healing. Transcriptome analysis is necessary to better understand the specific healing mechanisms of these two wound entities. Since no data are available to date, this study aims to fill the gap.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Digit Tip Wound		Experimental Wound Exudate from Digit Tip Wounds	Other: Digit Tip Wound
Split Skin Donor Site Wound		Active Comparator Wound Exudate from Split Skin Donor Site Wound	Other: Split Skin Donor Site Wound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Digit Tip Wound	Other	Digit Tip Wound Exudate Sample Collected while Dressing Change	Digit Tip Wound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Differences in RNA-Expression pattern	Differences in RNA-Expression pattern between Digit Tip Wound and Split Skin Donor Site Wound	5 Weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Digit Tip Wound: Wound Exudate from healthy patients: Consent-capable patients ≥18 years of age with clean Digit Tip Wound
Split Skin Donor Site Wound: Wound Exudate from healthy patients: Consent-capable patients ≥18 years of age with clean Split Skin Donor Site Wound

Exclusion Criteria:

Inflammation
Borderline
Infectious Disease

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Consent-capable patients ≥18 years of age with either Digit Tip Wound or Split Skin Donor Site

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Schleswig-Holstein		Lübeck	Schleswig-Holstein	23538	Germany