A prospective, monocentric clinical trial with adalimumab for topical treatment in chronic wounds

Phase 2

• Conditions: L97; Ulcer of lower limb, not elsewhere classified

• Registration Number: DRKS00000583
• Lead Sponsor: niversität Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-03
• Study Completion: 2012-06-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

at least one chronic wound without signs of infection. At the time point of study inclusion the wound must measure between 2,25 cm2 and 64 cm2.
- age =50 years
- at least 6 months existence without significant recovery although optimal wound care
- written informed consent

Exclusion Criteria

- pregnancy and nursing women,
- presence of severe hepatic insufficiency or renal insufficiency
- presence of hepatitis
- chronic severe focus of infection
- severe wound infection
- known hypersensitivity to Adalimumab or other components of IMP
- signs of latent or active tuberculosis
- clinically decompensated heart failure (NYHA III/IV),
- inusfficient compliance
- active demyelinating or other neurological disorder
- malignant or lymphoproliferative disorder
- known autoimmune disorder
- intake of other immunodepressive drugs
- women of child bearing potential (< 2 years after last menstruation)
- concurrent participation in other clinical trials
- persons dependent on investigator

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
percental reduction of wound area under serial treatment with Adalimumab, measurement by fotographical documentation and measurement of the wound

Secondary Outcome Measures

Name	Time	Method
- occurrence of new or aggravation of existent infection<br>- pain associated with chronic wound<br>- occurrence of possible contraindications