MedTrace Logo

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

NCT02348294 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-01-28

No results posted yet for this study

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.

Conditions

  • Pressure Ulcer
  • Diabetes Mellitus Type 2
  • Charcot- Osteoarthropathy

Interventions

OTHER

Shear- force 19 newton and 3,9 kpa pressure for half an hour

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-01-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02348294 on ClinicalTrials.gov