Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06330545
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-03-19
Brief Title:
Radiation Therapy for Dupuytrens Contracture Following Non-Surgical Release
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
A Prospective Clinical Trial of Radiation Therapy for Dupuytrens Contracture Following Surgical and Non-Surgical Release
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to learn about preventing recurrence of Dupuytrens Contracture The main question it aims to answer are
Does targeted radiation therapy decrease recurrence of Dupuytrens contracture after treatment with Collagenase Clostridium Histolyticum
Participants will undergo
Release of Dupuytrens Contracture after Collagenase Clostridium Histolyticum injection
Daily radiation therapy treatment for 5 days followed by 6-8 week rest period and then another course of 5 days of radiation therapy
Does targeted radiation therapy decrease recurrence of Dupuytrens contracture after treatment with Collagenase Clostridium Histolyticum
Participants will undergo
Release of Dupuytrens Contracture after Collagenase Clostridium Histolyticum injection
Daily radiation therapy treatment for 5 days followed by 6-8 week rest period and then another course of 5 days of radiation therapy
Detailed Description:
This is a prospective phase II trial where patients diagnosed with lateadvanced stage Dupuytrens Contracture DC who undergo successful Collagenase Clostridium Histolyticum CCH injection and release will receive a standardized regimen of adjuvant radiotherapy RT The study will be powered to assess the outcome in patients undergoing the combination of successful release followed by RT Patients will be monitored for acute and late toxicities while we evaluate disease recurrence defined as a 20 degree worsening of contracture in the presence of a palpable cord as compared to within 14 days from CCH injection or the need for medicalsurgical intervention to correct the new or worsening contracture
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None