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The Effect of Shear- Force at the Skin in Patients With Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT02348294
Recruitment Status : Unknown
Verified January 2015 by Maastricht University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 28, 2015
Last Update Posted : January 28, 2015
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:
  1. The objective of this study is to acquire knowledge about the development of reactive hyperaemia and inflammatory responses of the skin after shear- force and pressure loading. We want to investigate if patients with diabetes type 2 will develop more skin damage, because of a decreased microvascular function.
  2. The second objective of this study is: to investigate if the cytokine production of the skin is increased in patients with type 2 diabetes with a history of Charcot osteoarthropathy in comparison with patients with neuropathy without a history of Charcot osteoarthropathy.

The participant is asked to put his left arm on a support cushion. Then we mark an area of 2.5 cm x 3 cm with a permanent marker at the plantar aspect of the left fore-arm and the adhesive side of a Sebutape is placed within this area for collection of IL-1α/ total protein concentrations in a non- loaded situation (event 1) for two minutes. Second, we measure the cutaneous blood cell flux within the borders of the marked area with a Laser doppler. Finally, we measure the erythema index in this area with a colorimeter. Then we place the shear- pad over the marked area we apply 9,8 Newton (N) pressure with 19 N shear- force for half an hour. After this period a new Sebutape is placed for two minutes, followed by cutaneous blood cell flux and the erythema index measurement within the borders of the marked area. We repeat these measures after 15 minutes, 30 minutes, 45 minutes and 60 minutes, At the same time we performed the same experiment at the right arm, but instead of loading this arm with shear- force and pressure, we apply only 9,8 N pressure at this arm. The same measures with the sebutape, laser doppler and colorimeter are done before and after loading of the skin. The measures are repeated at 15 minutes, 30 minutes, 45 minutes and 60 minutes.


Condition or disease Intervention/treatment Phase
Pressure Ulcer Diabetes Mellitus Type 2 Charcot- Osteoarthropathy Other: Shear- force 19 newton and 3,9 kpa pressure for half an hour Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Measurement of Cytokines, Bloodflow and Erythema Index After Pressure and Shear- Force Loading in Patients With Diabetes Mellitus Type 2
Study Start Date : February 2015
Estimated Primary Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Healthy volunteers
Shear- force 19 newton and 3,9 kpa pressure for half an hour
Other: Shear- force 19 newton and 3,9 kpa pressure for half an hour
Diabetes Mellitus type 2 without neuropathy
Shear- force 19 newton and 3,9 kpa pressure for half an hour
Other: Shear- force 19 newton and 3,9 kpa pressure for half an hour
Diabetes Mellitus type 2 with neuropathy
Shear- force 19 newton and 3,9 kpa pressure for half an hour
Other: Shear- force 19 newton and 3,9 kpa pressure for half an hour
Charcot Osteoarhtopathy
Shear- force 19 newton and 3,9 kpa pressure for half an hour
Other: Shear- force 19 newton and 3,9 kpa pressure for half an hour



Primary Outcome Measures :
  1. Increase in IL-1alpha/ total protein ratio [ Time Frame: 0, 15, 30, 45, 60 minutes after intervention ]
  2. Increase in Cutaneous blood cell flux [ Time Frame: 0, 15, 30, 45, 60 minutes after intervention ]
  3. Increase in erythema index [ Time Frame: 0, 15, 30, 45, 60 minutes after intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Group A:
  • Healthy volunteers
  • > 40 years

Group B;

  • patients with Diabetes Mellitus type 2 (DM) without neuropathy
  • age > 40 years
  • Valk score < 4

Group C:

  • Patients with DM type 2 with neuropathy
  • age > 40 years
  • Valk score > 4

Group D

  • Patients with (pre)- existing Charcot Osteoarhtropathy
  • age > 40 years
  • Valk score > 4

Exclusion Criteria:

  • Trauma fore arms
  • Skin diseases (psoriasis, eczema)
  • NSAID use in last seven days
  • Bèta blocker use
  • Corticosteroids
  • Auto- immune diseases
  • Muscular dystrophy
  • Malignancy
  • Participant is unable to give informed consent
  • Peripheral artery disease (doppler eai <0.9)
  • Hab1c percentage last 3 months > 11%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348294


Contacts
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Contact: Luuk de Wert, MD +31618074833 luuk.wertde@mumc.nl

Sponsors and Collaborators
Maastricht University Medical Center

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02348294    
Other Study ID Numbers: NL50794.068.14
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: January 28, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Pressure Ulcer
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Skin Ulcer
Skin Diseases