Evaluation of Digit Tip and Split Skin Donor Site Transcriptome

August 7, 2023 updated by: Tobias Kisch, University Hospital Schleswig-Holstein
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • University of Schleswig-Holstein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. Digit Tip Wound: Wound Exudate from healthy patients: Consent-capable patients ≥18 years of age with clean Digit Tip Wound
  2. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Digit Tip Wound
Experimental Wound Exudate from Digit Tip Wounds
Other: Digit Tip Wound
Digit Tip Wound Exudate Sample Collected while Dressing Change
Split Skin Donor Site Wound
Active Comparator Wound Exudate from Split Skin Donor Site Wound
Other: Split Skin Donor Site Wound
Split Skin Donor Site Wound Exudate Sample while Dressing Change

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Schleswig-Holstein

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

April 30, 2022

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

August 7, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DigitTip2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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