Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00015695

Trial Description

start of 1:1-Block title

Title

Case Management for Chronic Wounds in Rhineland-Palatinate

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

VeMaWu RLP

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.vemawu.de

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The study investigates whether patients with chronic wounds accompanied by case management over a defined period of time are aware of the essential medical, nursing and patient-oriented parameters of wound treatment, such as: Cure rates, amputation, the incidence of wound infections and hospitalizations, as well as improve the quality of life and reduce the cost of illness. After an initial assessment of wound status and quality of life, at two points in time, after 6 and 12 months, the outcomes of the patients are accompanied by case management are compared with those of the patients in the standard care setting. For this purpose, people with poorly healing wounds are identified in the contract-based study institutions and randomly assigned to one of the two study groups.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The study uses quantitative and qualitative methods to evaluate the effects of accompanying people with chronic wounds through case management in addition to standard care. The case management comprises cooperation, coordination, coaching and educational measures according to individual target agreement.
A randomized-controlled, multicenter study on efficacy, a qualitative study on the mechanisms of case management, a cost-benefit analysis with routine data from the health insurances are carried out.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00015695
  •   2019/02/25
  •   [---]*
  •   yes
  •   Approved
  •   2018-13586, Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   ulcus cruris, decubitus, diabetic foot syndrome, chronic wound with healing stagnation over at least four weeks
  •   E10.5 -  Type 1 diabetes mellitus; With peripheral circulatory complications
  •   E10.7 -  Type 1 diabetes mellitus; With multiple complications
  •   E11.5 -  Type 2 diabetes mellitus; With peripheral circulatory complications
  •   E11.7 -  Type 2 diabetes mellitus; With multiple complications
  •   I70.24 -  [generalization I70.2: Atherosclerosis of arteries of extremities]
  •   I70.25 -  [generalization I70.2: Atherosclerosis of arteries of extremities]
  •   I73 -  Other peripheral vascular diseases
  •   I83.0 -  Varicose veins of lower extremities with ulcer
  •   I83.2 -  Varicose veins of lower extremities with both ulcer and inflammation
  •   I87.01 -  [generalization I87.0: Postthrombotic syndrome]
  •   I87.21 -  [generalization I87.2: Venous insufficiency (chronic)(peripheral)]
  •   I89.0 -  Lymphoedema, not elsewhere classified
  •   L89.1 -  Stage II decubitus ulcer
  •   L89.2 -  Stage III decubitus ulcer
  •   L89.3 -  Stage IV decubitus ulcer
  •   L97 -  Ulcer of lower limb, not elsewhere classified
  •   L98.4 -  Chronic ulcer of skin, not elsewhere classified
  •   R02 -  Gangrene, not elsewhere classified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   The patients with chronic wounds receive case management for six months and follow-up care for another six months, in addition to standard care. Wound healing and the status of essential medical, nursing and patient-oriented parameters are documented at three points in time.
  •   Patients with chronic wounds in the standard care receive the regular support as before, for example, to clean up the wound, appropriate wound dressings, the fight against infections, accompanying measures for wound healing and the treatment of pain. A visit is made three times to record wound status and other parameters as well as quality of life
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Health economics
  •   Parallel
  •   II
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Closure of wounds measured by wound size and wound depth, and amputation respectively, six months and twelve months after inclusion.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Quality of Life generic and disease-specific (EQ-5D, (Wound-QoL), anxiety and depression (HADS), satisfaction, Patient Benefit, self-care competence (PAM-13)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Doctor's Practice 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2018/12/03
  •   1000
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

E10.5, E10.7-, E11.5, E11.7-, I70.24, I70.25, I73.-, I83.0, I83.2, I87.01, I87.21, I89, L89.1, L89.2, L89.3, L97, L98.4, R02
(chronic) Wounds with healing stagnation over at least 4 weeks

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

age less than 18 years,
life expectancy less than 1 year,
untreated pAVK Fontaine stage IV,
diagnosis of dementia,
current addiction,
diagnosed psychiatric disorder (F23.-)
heart failure NYHA IV

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • mamedicon GmbH (Konsortialführer)
    • Mr.  Uwe  Imkamp 
    • Gewerbepark 18
    • 49143  Bissendorf
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • IMÖVG, Hochschule für Wirtschaft und Gesellschaft Ludwighafen
    • Ms.  Prof. Dr.  Elke  Raum 
    • Ernst-Boehe-Str. 4
    • 67059  Ludwigshafen
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Techniker Krankenkasse Landesvertretung Rheinland-Pfalz
    • Nikolaus-Otto-Str. 5
    • 55129  Mainz
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   +49 (0)6131 917 412
    •   [---]*
    •   [---]*
    •   http://www.tk.de
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • GWQ ServicePlus AG
    • Tersteegenstr. 28
    • 40474  Düsseldorf
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Institut für Management, Ökonomie und Versorgung im Gesundheitswesen der Hochschule für Wirtschaft und Gesellschaft
    • Mr.  Prof. Dr.  Manfred  Erbsland 
    • Ernst-Boehe-Str. 4
    • 67059  Ludwigshafen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • mamedicon GmbH VeMaWu
    • Ms.  Elke  Butzen-Wagner 
    • Gewerbepark 18
    • 49143  Bissendorf
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Innovationsausschuss beim Gemeinsamen Bundesausschuss
    • Wegelystr. 8
    • 10623  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.