Shockwave Therapy of Chronic Diabetic Foot Ulcers

NCT02251418 | Completed DMC

• 1 other identifier: 2014-ESWTULCER
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Foot ulcers are a feared complication among diabetic patients. The ulcers can cause pain, discomfort and reduced quality of life. The development of foot ulcers places the patients at a risk of amputation. In the Danish Health Care System a substantial effort is done to prevent and treat diabetic foot ulcers. A constant research of how to treat these wounds is ongoing. The goal is to optimize wound healing and prevent amputations. Extracorporeal shockwave therapy (ESWT) involves the use of a device that generates low-energy shockwaves through a headpiece, which is placed on the skin of the patient. A small amount of energy will be deposited in the tissue when shockwaves are applied. This stimulates the cells to produce substances that generate new vessels. No side effects to ESWT have been shown. Purpose: The investigators want to test whether shockwave therapy can improve wound healing among diabetic patients with foot ulcers. Hypothesis: The investigators hypothesize that shockwave therapy accelerates ulcer healing, increases blood flow, reduces pain, and has no side effects. Method: Patients who are interested in participation will be included in the study and divided by randomization into two groups of equal size. The first group is treated with ESWT in combination with regular guideline treatment. The second group is set up as control group and will only receive regular guideline treatment. The participants are examined in different ways to evaluate whether ESWT helps the healing of foot ulcers. The investigators want to measure tissue oxygen pressure and foot sense of touch. The foot ulcers are inspected for infection at every consultation, and a swab sample will be collected at enrollment. The size of the ulcers are measured and photographed each time. The investigators will count how many foot ulcers that are completely healed during the test period and measure the sizes of the remaining foot ulcers. The patients are asked to evaluate pain related to the foot ulcer. Data concerning participants' co morbidities and use of analgesic drugs are obtained from the patient journal and by patient interview. Significance: ESWT should be considered a supplement to existing clinical guidelines in wound management if shown to effectively help healing of diabetic foot ulcers. Improved healing should reduce the heavy workload on care and treatment regarding to these wounds. Hopefully, the frequency of amputations among diabetic patients will decline by implementing new treatment options for the diabetic foot.

Conditions

Diabetic Foot Ulcer

Keywords

Foot ulcer, diabetic; ESWT (Extracorporeal Shockwave Therapy); Endocrinology; Dermatology; Wound healing; Ischemia; Neovascularization, Physiologic; Pain management

Outcome Measures

Primary Outcomes (1)

• Ulcer area

  We will use digital photos to determine 49 days ulcer area and compare to trial entry.

  49 days after enrollment

Secondary Outcomes (25)

• Ulcer area (only intervention group)

  3-4 days after enrollment

• Ulcer area (only intervention group)

  6-7 days after enrollment

• Ulcer area (only intervention group)

  10-11 days after enrollment

• Ulcer area (only intervention group)

  13-14 days after enrollment

• Ulcer area (only intervention group)

  17-18 days after enrollment

Study Arms (2)

Extracorporeal shockwave therapy

EXPERIMENTAL

6 times extracorporeal shockwave therapy in 3 weeks. This arm also receives standard care treatment.

Device: Extracorporeal shockwave therapy

Control

NO INTERVENTION

Standard care treatment

Interventions

Extracorporeal shockwave therapy DEVICE

Also known as: STORZ DUOLITH SD1 T-top shockwave device

Extracorporeal shockwave therapy

Eligibility Criteria

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

You may qualify if:

• Patients receiving care and treatment in OUH Wound Clinic (Odense University Hospital, Denmark) with a diabetic foot ulcer.
• Wagner groups 1 and 2 (Wagner Ulcer Classification System)

You may not qualify if:

• Patients with an ulcer duration of less than 2 months
• Ulcer area less than 0,5 x 0,5 cm (or less than 0,25 cm2)
• Patients who have had vascular surgery performed within the past 2 months
• Patients who cannot give informed consent
• Patients who do not read or speak danish
• Wagner groups 3 and 4 (Wagner Ulcer Classification System)

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Southern Denmark: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (20)

• Bruun C, Siersma V, Guassora AD, Holstein P, de Fine Olivarius N. Amputations and foot ulcers in patients newly diagnosed with type 2 diabetes mellitus and observed for 19 years. The role of age, gender and co-morbidity. Diabet Med. 2013 Aug;30(8):964-72. doi: 10.1111/dme.12196. Epub 2013 Apr 26.

  PMID: 23617411 BACKGROUND

• Siersma V, Thorsen H, Holstein PE, Kars M, Apelqvist J, Jude EB, Piaggesi A, Bakker K, Edmonds M, Jirkovska A, Mauricio D, Ragnarson Tennvall G, Reike H, Spraul M, Uccioli L, Urbancic V, van Acker K, van Baal J, Schaper NC. Importance of factors determining the low health-related quality of life in people presenting with a diabetic foot ulcer: the Eurodiale study. Diabet Med. 2013 Nov;30(11):1382-7. doi: 10.1111/dme.12254. Epub 2013 Jul 15.

  PMID: 23758490 BACKGROUND

• Vileikyte L. Psychosocial and behavioral aspects of diabetic foot lesions. Curr Diab Rep. 2008 Apr;8(2):119-25. doi: 10.1007/s11892-008-0022-1.

  PMID: 18445354 BACKGROUND

• Goodridge D, Trepman E, Embil JM. Health-related quality of life in diabetic patients with foot ulcers: literature review. J Wound Ostomy Continence Nurs. 2005 Nov-Dec;32(6):368-77. doi: 10.1097/00152192-200511000-00007.

  PMID: 16301902 BACKGROUND

• Alva M, Gray A, Mihaylova B, Clarke P. The effect of diabetes complications on health-related quality of life: the importance of longitudinal data to address patient heterogeneity. Health Econ. 2014 Apr;23(4):487-500. doi: 10.1002/hec.2930. Epub 2013 Jul 11.

  PMID: 23847044 BACKGROUND

• Hirai FE, Tielsch JM, Klein BE, Klein R. Ten-year change in self-rated quality of life in a type 1 diabetes population: Wisconsin Epidemiologic Study of Diabetic Retinopathy. Qual Life Res. 2013 Aug;22(6):1245-53. doi: 10.1007/s11136-012-0245-0. Epub 2012 Aug 8.

  PMID: 22872499 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

• Game FL, Hinchliffe RJ, Apelqvist J, Armstrong DG, Bakker K, Hartemann A, Londahl M, Price PE, Jeffcoate WJ. A systematic review of interventions to enhance the healing of chronic ulcers of the foot in diabetes. Diabetes Metab Res Rev. 2012 Feb;28 Suppl 1:119-41. doi: 10.1002/dmrr.2246.

  PMID: 22271737 BACKGROUND

• Gottrup F, Apelqvist J. Present and new techniques and devices in the treatment of DFU: a critical review of evidence. Diabetes Metab Res Rev. 2012 Feb;28 Suppl 1:64-71. doi: 10.1002/dmrr.2242.

  PMID: 22271726 BACKGROUND

• Wang CJ. Extracorporeal shockwave therapy in musculoskeletal disorders. J Orthop Surg Res. 2012 Mar 20;7:11. doi: 10.1186/1749-799X-7-11.

  PMID: 22433113 BACKGROUND

• Zimpfer D, Aharinejad S, Holfeld J, Thomas A, Dumfarth J, Rosenhek R, Czerny M, Schaden W, Gmeiner M, Wolner E, Grimm M. Direct epicardial shock wave therapy improves ventricular function and induces angiogenesis in ischemic heart failure. J Thorac Cardiovasc Surg. 2009 Apr;137(4):963-70. doi: 10.1016/j.jtcvs.2008.11.006.

  PMID: 19327525 BACKGROUND

• Kiyota H, Ohishi Y, Asano K, Hasegawa N, Madarame J, Miki K, Kato N, Kimura T, Ishiyama T, Maeda S, Shimomura T, Shiono Y, Miki J. Extracorporeal shock wave treatment for Peyronie's disease using EDAP LT-02; preliminary results. Int J Urol. 2002 Feb;9(2):110-3. doi: 10.1046/j.1442-2042.2002.00430.x. No abstract available.

  PMID: 12033197 BACKGROUND

• Schaden W, Thiele R, Kolpl C, Pusch M, Nissan A, Attinger CE, Maniscalco-Theberge ME, Peoples GE, Elster EA, Stojadinovic A. Shock wave therapy for acute and chronic soft tissue wounds: a feasibility study. J Surg Res. 2007 Nov;143(1):1-12. doi: 10.1016/j.jss.2007.01.009. Epub 2007 Sep 27.

  PMID: 17904157 BACKGROUND

• Saggini R, Figus A, Troccola A, Cocco V, Saggini A, Scuderi N. Extracorporeal shock wave therapy for management of chronic ulcers in the lower extremities. Ultrasound Med Biol. 2008 Aug;34(8):1261-71. doi: 10.1016/j.ultrasmedbio.2008.01.010. Epub 2008 Apr 18.

  PMID: 18394777 BACKGROUND

• Wang CJ, Kuo YR, Wu RW, Liu RT, Hsu CS, Wang FS, Yang KD. Extracorporeal shockwave treatment for chronic diabetic foot ulcers. J Surg Res. 2009 Mar;152(1):96-103. doi: 10.1016/j.jss.2008.01.026. Epub 2008 Mar 7.

  PMID: 18619622 BACKGROUND

• Moretti B, Notarnicola A, Maggio G, Moretti L, Pascone M, Tafuri S, Patella V. The management of neuropathic ulcers of the foot in diabetes by shock wave therapy. BMC Musculoskelet Disord. 2009 May 27;10:54. doi: 10.1186/1471-2474-10-54.

  PMID: 19473538 BACKGROUND

• Wang CJ, Wu RW, Yang YJ. Treatment of diabetic foot ulcers: a comparative study of extracorporeal shockwave therapy and hyperbaric oxygen therapy. Diabetes Res Clin Pract. 2011 May;92(2):187-93. doi: 10.1016/j.diabres.2011.01.019. Epub 2011 Apr 6.

  PMID: 21310502 BACKGROUND

• Romeo P, Lavanga V, Pagani D, Sansone V. Extracorporeal shock wave therapy in musculoskeletal disorders: a review. Med Princ Pract. 2014;23(1):7-13. doi: 10.1159/000355472. Epub 2013 Nov 5.

  PMID: 24217134 BACKGROUND

• Frairia R, Berta L. Biological effects of extracorporeal shock waves on fibroblasts. A review. Muscles Ligaments Tendons J. 2012 Apr 1;1(4):138-47. Print 2011 Oct.

  PMID: 23738262 BACKGROUND

• Notarnicola A, Moretti B. The biological effects of extracorporeal shock wave therapy (eswt) on tendon tissue. Muscles Ligaments Tendons J. 2012 Jun 17;2(1):33-7. Print 2012 Jan.

  PMID: 23738271 BACKGROUND

Related Links

• Statens Serum Institut (SSI) is responsible for research-based health surveillance, rational use of IT in the Danish healthcare system and prevention and control of infectious diseases, biological threats and congenital disorders.

MeSH Terms

Conditions

Diabetic Foot; Ischemia; Neovascularization, Pathologic; Agnosia

Interventions

Extracorporeal Shockwave Therapy

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Metaplasia; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Lars Lund, Professor

  Odense University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical student

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: September 29, 2014
• Study Start: February 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 30, 2016

Record last verified: 2016-03

Locations

DK (1)