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

Phase 1

• Conditions: Chronic stasis ulcer; MedDRA version: 13.1Level: LLTClassification code 10047246Term: Venous stasis ulcerSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2009-015749-22-DE
• Lead Sponsor: niversity of Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-20
• Study Completion: 2012-11-30
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

- at least one chronic wound without signs of infection
- age >=50 years
- at least 6 months peristence without significant recovery despite optimal wound care, the wound must measure between 2.24cm2 and 64cm2
- written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- pregnant and nursing women,
- pre-existing severe hepatic or renal insufficiency
- pre-existing of hepatitis
- chronic severe focus of infection
- severe wound infection
- known hypersensitivity to Adalimumab or other components of the IMP
- signs of latent or active tuberculosis
- decompensated cardiac insufficiency (NYHA III/IV)
- lack of treatment compliance
- active demyelinating or other neurological disorder
- malignant or lymphoproliferative disorder
- known autoimmune disorder
- consumption of other immunosuppresive drugs
- women of child bearing potential (< 2 years after last menstruation)
- concurrent participation in other studys
- individuals dependent on investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Is there a significant influence on wound healing in chronic wounds after regular treatment did not improve wound healing any further?;Secondary Objective: Secondary questions of the study concern:<br>- occurrence of new or aggravation of an existent infection.<br>- pain associated with chronic wound<br>- occurrence of potential contraindications<br>;Primary end point(s): Reduction of wound area under serial treatment with Adalimumab;Timepoint(s) of evaluation of this end point: End of application series, i.e. day 8 (+/-2)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - course of wound area during treatment<br>- wound pain (visual analogue scale)<br>- occurence or incidence of infections<br>- results of mikrobiologic swab, in case of clinical suspicion of infection<br>- development of possible contraindications (each visit; following the SmPC)<br>- development of TNF-alpha-antibodies<br>- other (S)AE;Timepoint(s) of evaluation of this end point: every visit, i.e. days 1-8 and Follow-up: 4 and 12 weeks after last application of IMP