Passive Training as a Treatment for Diabetic Foot Ulcers

NCT02785198 | Terminated DMC

• 1 other identifier: H-15008102
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Overall project design: This PhD project involves a randomized study on diabetic individuals with healing resistant wounds, comparing the effect of passive movement of the lower limb with standard treatment of diabetic wounds. How to effectively improve the condition of peripheral arterial disease is limited. The primary purpose of this study is to uncover whether passive movement of the lower limb will influence muscle oxygen demand and thereby increasing blood flow. An increase in muscle oxygen demand is likely to increase both blood flow rate and the number of capillaries, which would induce the healing of wounds, that were not previously possible. The secondary purpose is to increase understanding of the pathophysiological processes in wound healing through the study of biochemical markers of vascularization, inflammation and stem cell recruitment in blood samples. Further on analyzing the skin and muscle biopsies of the number and quality of endothelial cells and Capillary density and to develop new quantifiable methods to evaluate wound healing in. The project is a randomized trial, consisting of simple passive training to improve blood vessel function, increase the growth of the smallest blood vessels, thereby preventing ulceration and ultimately amputation.

Conditions

Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (4)

• Wound healing change quantified by digital photo planimetry

  The digital photo planimetry measurements are compared to the baseline measurement at week 0

  Photos are taken at week 0 and 8

• The change in Wagner's wound classification.

  measurements at baseline are compared to week 8

  week 0 and 8

• The change in Wagner's wound classification.

  The measurements at week 3, 5 and 16 are compared to the baseline week 0 and 8

  week 3, 5 and 16

• Wound healing change quantified by digital photo planimetry

  The measurements at week 3, 5 and 16 are compared to the baseline week 0 and 8

  week 3, 5 and 16

Secondary Outcomes (31)

• Perfusion of the lower extremity.

  week 0, 3, 5, 8 and 16.

• Distal blood pressure measurement.

  week 0 and 8.

• The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.

  Week 0, 5 and 8

• Histological changes of the muscle tissue.

  Week 0,5 and 8

• Histological changes of the tissue composition in the edge of the wound.

  Week 0,5 and 8

Study Arms (2)

Control group

NO INTERVENTION

A control group receiving standard wound treatment consisting of debridement, dressings, compression, offloading footwear and if necessary antibiotics.

Passive training group

EXPERIMENTAL

An Intervention group doing passive exercise for 8 weeks in knee extensor machine, and receiving standard wound treatment consisting of debridement, dressings, compression, offloading footwear and if necessary antibiotics.

Device: Passive knee extensor machine

Interventions

Passive knee extensor machine DEVICE

The passive training machine, moves both legs from flexion to extension and back, 60 times per minute in 1 hour, 3 times per week. ROM is 60 degrees

Passive training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
• Diabetes mellitus according to the World Health Organisation (WHO) criteria (see http://www.who.int/diabetes/publications/en/ ) and a stable treatment treated in a period of 14 days prior to screening with insulin or an oral antidiabetic agent. Stable is defined as stable HBA1c.
• \. Foot ulcer: size: diameter \> 1cm. Duration of wound \> 6 weeks Location: Full thickness skin defect distal to the malleoli.
• \. Male or female, age \>18 years at the time of signing informed consent. 6. Non-dementia diagnosis.

You may not qualify if:

• Major infection; acute cellulitis, osteomyelitis or gangrene anywhere in the affected extremity.
• Malignant disease
• Major traumatic tissue damage.
• Major lower extremity amputation.

Sponsors & Collaborators

• Herlev Hospital: lead
• University of Copenhagen: collaborator

Study Sites (1)

Herlev Hospital

Herlev, Capital Region of Denmark, 2730, Denmark

Location

Related Publications (13)

• Moxey PW, Gogalniceanu P, Hinchliffe RJ, Loftus IM, Jones KJ, Thompson MM, Holt PJ. Lower extremity amputations--a review of global variability in incidence. Diabet Med. 2011 Oct;28(10):1144-53. doi: 10.1111/j.1464-5491.2011.03279.x.

  PMID: 21388445 BACKGROUND

• Tennvall GR, Apelqvist J, Eneroth M. Costs of deep foot infections in patients with diabetes mellitus. Pharmacoeconomics. 2000 Sep;18(3):225-38. doi: 10.2165/00019053-200018030-00003.

  PMID: 11147390 BACKGROUND

• Baltzis D, Eleftheriadou I, Veves A. Pathogenesis and treatment of impaired wound healing in diabetes mellitus: new insights. Adv Ther. 2014 Aug;31(8):817-36. doi: 10.1007/s12325-014-0140-x. Epub 2014 Jul 29.

  PMID: 25069580 BACKGROUND

• Hinchliffe RJ, Valk GD, Apelqvist J, Armstrong DG, Bakker K, Game FL, Hartemann-Heurtier A, Londahl M, Price PE, van Houtum WH, Jeffcoate WJ. A systematic review of the effectiveness of interventions to enhance the healing of chronic ulcers of the foot in diabetes. Diabetes Metab Res Rev. 2008 May-Jun;24 Suppl 1:S119-44. doi: 10.1002/dmrr.825.

  PMID: 18442185 BACKGROUND

• Gary Sibbald R, Woo KY. The biology of chronic foot ulcers in persons with diabetes. Diabetes Metab Res Rev. 2008 May-Jun;24 Suppl 1:S25-30. doi: 10.1002/dmrr.847.

  PMID: 18442179 BACKGROUND

• Jorgensen ME, Almdal TP, Faerch K. Reduced incidence of lower-extremity amputations in a Danish diabetes population from 2000 to 2011. Diabet Med. 2014 Apr;31(4):443-7. doi: 10.1111/dme.12320. Epub 2013 Oct 21.

  PMID: 24111834 BACKGROUND

• Vogel TR, Petroski GF, Kruse RL. Impact of amputation level and comorbidities on functional status of nursing home residents after lower extremity amputation. J Vasc Surg. 2014 May;59(5):1323-30.e1. doi: 10.1016/j.jvs.2013.11.076. Epub 2014 Jan 7.

  PMID: 24406089 BACKGROUND

• McDonald S, Sharpe L, Blaszczynski A. The psychosocial impact associated with diabetes-related amputation. Diabet Med. 2014 Nov;31(11):1424-30. doi: 10.1111/dme.12474. Epub 2014 May 24.

  PMID: 24766143 BACKGROUND

• Jeffcoate WJ, Harding KG. Diabetic foot ulcers. Lancet. 2003 May 3;361(9368):1545-51. doi: 10.1016/S0140-6736(03)13169-8.

  PMID: 12737879 BACKGROUND

• Pence BD, Woods JA. Exercise, Obesity, and Cutaneous Wound Healing: Evidence from Rodent and Human Studies. Adv Wound Care (New Rochelle). 2014 Jan 1;3(1):71-79. doi: 10.1089/wound.2012.0377.

  PMID: 24761347 BACKGROUND

• Rasmussen BSB, Yderstraede KB, Carstensen B, Skov O, Beck-Nielsen H. Substantial reduction in the number of amputations among patients with diabetes: a cohort study over 16 years. Diabetologia. 2016 Jan;59(1):121-129. doi: 10.1007/s00125-015-3781-7. Epub 2015 Nov 22.

  PMID: 26590707 BACKGROUND

• Hellsten Y, Rufener N, Nielsen JJ, Hoier B, Krustrup P, Bangsbo J. Passive leg movement enhances interstitial VEGF protein, endothelial cell proliferation, and eNOS mRNA content in human skeletal muscle. Am J Physiol Regul Integr Comp Physiol. 2008 Mar;294(3):R975-82. doi: 10.1152/ajpregu.00677.2007. Epub 2007 Dec 19.

  PMID: 18094062 BACKGROUND

• Hoier B, Rufener N, Bojsen-Moller J, Bangsbo J, Hellsten Y. The effect of passive movement training on angiogenic factors and capillary growth in human skeletal muscle. J Physiol. 2010 Oct 1;588(Pt 19):3833-45. doi: 10.1113/jphysiol.2010.190439.

  PMID: 20693292 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Tue Smith Joergensen, MD

  Herlev and Gentofte Hospital, The Department of Orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 13, 2016
• First Posted: May 27, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)