Status:
WITHDRAWN
LeucoPatch® in Nonhealing Wounds With Exposed Bone or Tendon Study
Lead Sponsor:
Jais Oliver Berg
Collaborating Sponsors:
Nordsjaellands Hospital
Reapplix
Conditions:
Wound Healing Delayed
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The trial compare the healing rate of chronic wounds with exposed tendon or bone ('problematic wound area') with LeucoPatch® treatment for 8 up to 16 weeks in addition to usual care versus usual care....
Detailed Description
A certain subpopulation of plastic surgery patients has chronic, non-healing wounds with exposed bone or tendon e.g. located on the scalp or extremities. The chronic non-healing wounds are characteriz...
Eligibility Criteria
Inclusion
- Written informed consent obtained before any trial related procedures are performed
- Aged ≥18 years
- A documented clinically relevant history of chronic wound with exposed tendon and/or bone. Chronic is defined as a non-healing wound over the past 4 weeks with standard care in a specialized clinic.
- 'Problematic wound area' between 0.25 and 10.0 cm2 measured by Image J at S1- irrespective of the total wound size
- The subject must be willing and able to comply with the trial protocol
Exclusion
- Haemoglobin \< 6.0 mmol/l available at screening (see 10.10)
- Non-compliance with blood-letting
- Clinically infected wound or suspected osteomyelitis in the wound area
- For lower extremity wounds: Critical peripheral artery disease (absence of foot pulse and Ankle-Branchial Pressure Index, ABPI \<0.9 and ankle blood pressure \< 50 mmHg)
- For lower extremity wounds: History of vascular by-pass graft or other endovascular intervention within 3 months prior to inclusion.
- Malignancy in the wound area
- Need for dialysis
- Hemophilia, leukaemia or other significant blood disease
- History of alcohol or drug abuse within the last year
- Weight abnormality (BMI \< 20 kg/m2 or \>30 kg/m2)
- Pregnant or lactating woman
- Women of childbearing potential who are not using sufficient contraceptives
- Patient has previously been randomised in this study
- Participation in another investigational drug trial within the last 10 weeks
Key Trial Info
Start Date :
November 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03370055
Start Date
November 2 2017
End Date
May 1 2020
Last Update
November 18 2020
Active Locations (1)
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1
Herlev - Gentofte Hospital
Herlev, Regionh, Denmark, 2730