Trial document




drksid header

  DRKS00021098

Trial Description

start of 1:1-Block title

Title

Effects of Serial locoregional application of water-filtered infrared a radiation in patients with systemic sclerosis and raynauds' Syndrom of the hands

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

Trial Acronym

wiRASSc

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

URL of the Trial

[---]*

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

Brief Summary in Lay Language

Progressive systemic sclerosis is a generalized autoimmune disease characterized by excessive fibrosis and sclerosis of collagenous connective tissue, especially in-volving the skin, blood vessels and internal organs. Raynaud’s syndrome on the fingers and/or toes manifests itself in approximately 90% of the cases. In advanced cases it can result in serious soft tissue defects with necrosis. The pharmaceutical therapy options for this problem are still very limited.
In the intended study the aim is to test the effect of serial loco regional water filtered infrared A (lwIRA) as an add-on therapy to standard therapy in patients with systemic sclerosis and raynauds Syndrom on clinical and laboratory-chemical parameters.

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

Brief Summary in Scientific Language

Systemic sclerosis (SSc) is a rare to very rare autoimmune systemic disease asso-ciated with significantly increased morbidity and inevitable mortality. This disease is characterized by i) fibrosis, ii) obliterative vasculopathy and iii) activation of the im-mune system with a low inflammatory component.
The obliterating vasculopathy is expressed, for example, in Raynaud's syndrome (RS), which affects up to 98% of patients. Depending on the severity of the RS, pain, functional impairment, digital ulceration with superinfection and amputation of the affected limbs can occur due to acral underperfusion.
In addition to pharmacological therapy of the RS, which is especially based on cal-cium channel blockers, sildenafil, bosentan and iloprost, also physical medicine therapy modalities such as CO2 hand and foot baths have been proven very effective.
In this context, the study investigates the effect of an additive locoregional water-filtered infrared treatment as an add-on to multimodal standard therapy in patients with SSc and RS of the hands.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

No

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00021098
  •   2020/03/18
  •   [---]*
  •   yes
  •   Approved
  •   17/16, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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

  •   M34.0 -  Progressive systemic sclerosis
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients with SSc diagnosed according to the ACR/EULAR classification criteria of 2013 with Raynaud's syndrome of the hands, who in addition to the multimodal standard therapy receive an additive serial locoregional therapy with water-filtered infrared A radiation (2x/day for 8 days)
  •   Patients with SSc diagnosed according to the 2013 ACR/EULAR classification criteria with Raynaud's syndrome of the hands receiving standard multimodal therapy
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome


Pain in the hands (VAS 0-100mm) after intervention / non-intervention

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

Secondary Outcome

-Pain in the hands (VAS 0-100mm) after 2 weeks of successful/completed therapy
-Tension feeling/ Tensed feeling/ Tensed sensation/ Stiffness of the hands (VAS 0-100mm) i) immediately after and ii) 2 weeks after therapy
-Severity of Raynaud's attacks (VAS 0-100mm) i) immediately after and ii) 2 weeks after therapy
-Length of Raynaud's attacks (in minutes) i) immediately after and ii) 2 weeks after therapy
-General satisfaction with hands (VAS 0-100mm) i) immediately after and ii) 2 weeks after therapy
- Satisfaction with general well-being (VAS 0-100mm) i) immediately after and ii) 2 weeks after therapy
-Extent of difficulties in everyday life caused by SSc (VAS 0-100mm) i) immediately after and ii) 2 weeks after therapy
- Extent of quality of life reduction by SSc (VAS 0-100mm) i) immediately after and ii) 2 weeks after therapy
-Evaluation of the success of the wIRAS therapy i) immediately after and ii) 2 weeks after therapy
-Evaluation of the success of all therapeutic measures i) immediately after and ii) 2 weeks after therapy
-Measurement of hand force/ power i) immediately after therapy
-Functionality (HAQ, FFbH) i) immediately after and ii) 2 weeks after therapy
-CO2 measurements (relative blood flow and post-capillary oxygen saturation) on the index and ring finger of the hand i) immediately after and ii) 2 weeks after therapy
- change in levels of molecular parameters of angiogenesis (VEGF, PDGF)

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

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2020/03/01
  •   60
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria


Patients with systemic sclerosis who meet the ACR/EULAR classification criteria of 2013 and have Raynaud's syndrome of the hands, are able to speak German, are able to give consent and sign the informed consent form

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

Exclusion Criteria

Acute infections of the hands / fingers. Heat intolerance

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Campus Kerckhoff der Jusuts-Liebig-Universität Gießen, Abteilung für Rheumatologie, Immunologie, Osteologie und Physikalische Medizin
    • Mr.  Univ.-Prof. Dr. med.  Uwe  Lange 
    • Benekestr. 2-8
    • 61231  Bad Nauheim
    • 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 scientific-contact
    • Campus Kerckhoff der Jusuts-Liebig-Universität Gießen, Abteilung für Rheumatologie, Immunologie, Osteologie und Physikalische Medizin
    • Mr.  Dr. med.  Philipp  Klemm 
    • Benekestr. 2-8
    • 61231   Bad Nauheim
    • 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
    • Campus Kerckhoff der Jusuts-Liebig-Universität Gießen, Abteilung für Rheumatologie, Immunologie, Osteologie und Physikalische Medizin
    • Mr.  Dr. med.  Philipp  Klemm 
    • Benekestr. 2-8
    • 61231   Bad Nauheim
    • 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
    • Campus Kerckhoff der Jusuts-Liebig-Universität Gießen, Abteilung für Rheumatologie, Immunologie, Osteologie und Physikalische Medizin
    • Mr.  Univ.-Prof. Dr. med.  Uwe  Lange 
    • Benekestr. 2-8
    • 61231  Bad Nauheim
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Dr. med. h.c. Erwin Braun Stiftung
    • Aeschenvorstadt 48
    • 4051  Basel
    • Switzerland
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    end of 1:1-Block address contact otherSupport
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

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