A Study Measuring the Effectiveness of Combined Modulated Ultrasound and Electric Current Stimulation as an Adjunctive Treatment in Treating Diabetic Foot Ulcers

NCT03458286 | Unknown DMC

• 1 other identifier: DFUCUSECS
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aims to investigate if combined modulated ultrasound and electric current stimulation (CUSECS) is an effective adjunctive treatment to use to treat diabetic foot ulcers when compared against usual care. Consenting patients with diabetic foot ulcers (DFUS) and meet the inclusion criteria will be randomly allocated in to either an experimental group or a control group. The experimental group will receive the adjunctive CUSECS treatment along their usual treatment for their diabetic ulcer. They will be required to attend the Diabetic Foot clinic in St. James's hospital twice a week for a maximum of eight weeks. The CUSECS is provided by attaching small electrodes around the ulcers to provide electric current stimulation. A probe is used on the ulcers to provide the ultrasound waves. Both aiming to increase the blood flow to an area to increase wound healing. The control group will be required to attend the diabetic foot clinic for their usual care for their diabetic foot ulcer once a week for a maximum for eight weeks. Once a week both groups ulcers will be assessed and measured and a photograph solely of the wound will be taken for documentation of wound healing. Wound pain as determined using the 0-10 Numeric pain rating scale will also be measured once a week. The movement in participant's ankle will be measured (flexion, extension, inversion) at the start and at the end of the study to see if treatment has improved its movement. As part of this study participants' will also be requested to fill out a SF-36 questionnaire at the start and at the end of the 8 week trial. This questionnaire evaluates a person's health related quality of life in which the research wants to see if it is affected by a diabetic foot ulcer. The self-efficacy of participants will also be assessed using PROMIS® Item Bank v.1.0 - General Self-Efficacy at the start and at the end of the 8 week trial. The cost of treatment for each arm will be calculated taking into account both direct (cost of treatments, consumables etc.) and indirect costs (loss of earnings, travel, parking etc.). Therefore, as part of this study, participants will be asked about mode of transport and transport time to and from the clinic and if their diabetic foot ulcer has affected their ability to work. Diabetic foot ulcer reoccurrence rates will be monitored in both groups by a follow up appointment 4 weeks after each group completes treatment or monitoring. Data from both groups will be examined and compared to see if CUSECS is effective in healing DFUs. The primary outcome of interest is wound healing and is determined by the number of wounds healed and the time to complete wound healing within eight weeks. All data will be stored confidentially. The study hypothesis is that there is be increased healing rates in subjects treated with CUSECS in combination with standard care compared to those treated with standard care alone. This study aims to provide evidence for continuing improvement in treatment for those suffering with diabetic foot ulcers.

Conditions

Diabetic Foot Ulcer

Keywords

Diabetic Foot Ulcers; Chronic; Combined ultrasound and electric current stimulation; Adjunctive therapy

Outcome Measures

Primary Outcomes (1)

• Total wound healing

  The number of wounds that completely heal in the experimental group compared to control group. This may be presented in either or both following formats: * The proportion of wounds completely healed (frequency of complete healing by group). * The time to complete wound healing.

  8 weeks

Secondary Outcomes (7)

• Changes in wound bed condition.

  8 weeks

• Patient reported quality of life

  8 weeks

• Wound pain

  8 weeks

• Self-efficacy

  8 weeks

• Cost of treatment per arm (economic analysis direct cost and in-direct costs).

  8 weeks

Study Arms (2)

Control group

NO INTERVENTION

The control group will be required to attend the diabetic foot clinic for their usual care for their diabetic foot ulcer with weekly review for a maximum of eight weeks. They will also have a follow up appointment 4 weeks after completion of treatment.

Experimental Arm

EXPERIMENTAL

A device- BRH-A2 wound healing device will provide Combined ultrasound and electric current stimulation (CUSECS) treatment which is the intervention for this arm. Participants in this group will receive an adjunctive combined ultrasound and electric current stimulation (CUSECS) treatment along their usual treatment for their diabetic ulcer twice weekly for 8 weeks using the BRH-A2 wound healing device. They will also have a follow up appointment 4 weeks after completion of treatment.

Device: BRH-A2 wound healing device

Interventions

BRH-A2 wound healing device DEVICE

Combined ultrasound and electric current stimulation (CUSECS) is a combination therapy provided by the BRH-A2 wound healing device. This study is testing the effectiveness of the treatment CUSECS. The electric current stimulation is provided by attaching small electrodes around the ulcers. A probe is used on the ulcers to provide the ultrasound waves. Both aiming to increase the blood flow to an area to increase wound healing.

Experimental Arm

Eligibility Criteria

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

You may qualify if:

• Participants must be a diagnosed diabetic.
• Participants who have the capacity to provide informed consent prior to participation in the study.
• Participants must be aged 18 or over on the day of the informed consent.
• Participants have an ulcer that has been present for at least 60 and less than 365 days.
• Participants and/or caregiver must be willing and able to comply with all study procedures and scheduled follow-up visits, for the duration of the study.

You may not qualify if:

• Subjects without capacity to consent or those who do not provide informed consent.
• Ulcers that have a total surface area greater than 15 cm2 as measured by a member of the study staff.
• Unwilling to continue with their standard wound care therapy for the study duration.
• Clinical evidence of infection or gangrene on any part of the affected foot or leg. A subject with clinically infected wound(s) who otherwise meets the study criteria may enter the study after successful treatment of the for wound infection.
• Target ulcer involving exposure of tendon, bone or joint capsule, or any tunnelling or sinus tracts (it is acceptable to have ulcers extending through the dermis and into subcutaneous tissue with presence of granulation tissue).
• Target ulcer treatment with a wound dressing containing human growth factors, engineering tissues, or skin substitutes (e.g. Apligraf, Dermagraf, Regranex etc) within 30 days of screening visit or planned during the study duration.
• History of bone cancer or metastatic disease of the affected limb, radiation therapy to the affected limb, or chemotherapy within the 12 months prior to screening visit.
• Suspected or confirmed malignancy of the wound.
• Participation in another drug or device study for the treatment of diabetic foot ulcer within 30 days of screening visit.
• Vascular procedures performed within 30 days of screening visit.
• Active bleeding tissue or untreated haemorrhagic conditions.
• Active or suspected DVT or thrombophlebitis.
• Conditions which, in the judgment of the treating investigator, may severely compromise the subject's ability to complete the study.

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead
• Jagmed Limited: collaborator

Related Publications (22)

• Monteiro-Soares M, Boyko EJ, Ribeiro J, Ribeiro I, Dinis-Ribeiro M. Predictive factors for diabetic foot ulceration: a systematic review. Diabetes Metab Res Rev. 2012 Oct;28(7):574-600. doi: 10.1002/dmrr.2319.

  PMID: 22730196 BACKGROUND

• Dubsky M, Jirkovska A, Bem R, Fejfarova V, Skibova J, Schaper NC, Lipsky BA. Risk factors for recurrence of diabetic foot ulcers: prospective follow-up analysis in the Eurodiale subgroup. Int Wound J. 2013 Oct;10(5):555-61. doi: 10.1111/j.1742-481X.2012.01022.x. Epub 2012 Jun 19.

  PMID: 22712631 BACKGROUND

• Apelqvist J. Diagnostics and treatment of the diabetic foot. Endocrine. 2012 Jun;41(3):384-97. doi: 10.1007/s12020-012-9619-x. Epub 2012 Feb 25.

  PMID: 22367583 BACKGROUND

• Apelqvist J, Larsson J. What is the most effective way to reduce incidence of amputation in the diabetic foot? Diabetes Metab Res Rev. 2000 Sep-Oct;16 Suppl 1:S75-83. doi: 10.1002/1520-7560(200009/10)16:1+3.0.co;2-8.

  PMID: 11054894 BACKGROUND

• Kuehn BM. Prompt response, multidisciplinary care key to reducing diabetic foot amputation. JAMA. 2012 Jul 4;308(1):19-20. doi: 10.1001/jama.2012.6778. No abstract available.

  PMID: 22760271 BACKGROUND

• Winkley K, Sallis H, Kariyawasam D, Leelarathna LH, Chalder T, Edmonds ME, Stahl D, Ismail K. Five-year follow-up of a cohort of people with their first diabetic foot ulcer: the persistent effect of depression on mortality. Diabetologia. 2012 Feb;55(2):303-10. doi: 10.1007/s00125-011-2359-2. Epub 2011 Nov 6.

  PMID: 22057196 BACKGROUND

• Game FL, Apelqvist J, Attinger C, Hartemann A, Hinchliffe RJ, Londahl M, Price PE, Jeffcoate WJ; International Working Group on the Diabetic Foot. Effectiveness of interventions to enhance healing of chronic ulcers of the foot in diabetes: a systematic review. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:154-68. doi: 10.1002/dmrr.2707.

  PMID: 26344936 BACKGROUND

• Peters EJ, Lipsky BA, Aragon-Sanchez J, Boyko EJ, Diggle M, Embil JM, Kono S, Lavery LA, Senneville E, Urbancic-Rovan V, Van Asten SA, Jeffcoate WJ; International Working Group on the Diabetic Foot. Interventions in the management of infection in the foot in diabetes: a systematic review. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:145-53. doi: 10.1002/dmrr.2706.

  PMID: 26344844 BACKGROUND

• Avrahami R, Rosenblum J, Gazes M, Rosenblum S, Litman L. The Effect of Combined Ultrasound and Electric Field Stimulation on Wound Healing in Chronic Ulcerations. Wounds. 2015 Jul;27(7):199-208.

  PMID: 26192738 BACKGROUND

• Junger M, Arnold A, Zuder D, Stahl HW, Heising S. Local therapy and treatment costs of chronic, venous leg ulcers with electrical stimulation (Dermapulse): a prospective, placebo controlled, double blind trial. Wound Repair Regen. 2008 Jul-Aug;16(4):480-7. doi: 10.1111/j.1524-475X.2008.00393.x.

  PMID: 18638265 BACKGROUND

• Kloth LC. Electrical Stimulation Technologies for Wound Healing. Adv Wound Care (New Rochelle). 2014 Feb 1;3(2):81-90. doi: 10.1089/wound.2013.0459.

  PMID: 24761348 BACKGROUND

• Kloth LC. Electrical stimulation for wound healing: a review of evidence from in vitro studies, animal experiments, and clinical trials. Int J Low Extrem Wounds. 2005 Mar;4(1):23-44. doi: 10.1177/1534734605275733.

  PMID: 15860450 BACKGROUND

• Peters EJ, Lavery LA, Armstrong DG, Fleischli JG. Electric stimulation as an adjunct to heal diabetic foot ulcers: a randomized clinical trial. Arch Phys Med Rehabil. 2001 Jun;82(6):721-5. doi: 10.1053/apmr.2001.23780.

  PMID: 11387573 BACKGROUND

• Ennis WJ, Foremann P, Mozen N, Massey J, Conner-Kerr T, Meneses P. Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multicenter study. Ostomy Wound Manage. 2005 Aug;51(8):24-39.

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• Yao M, Hasturk H, Kantarci A, Gu G, Garcia-Lavin S, Fabbi M, Park N, Hayashi H, Attala K, French MA, Driver VR. A pilot study evaluating non-contact low-frequency ultrasound and underlying molecular mechanism on diabetic foot ulcers. Int Wound J. 2014 Dec;11(6):586-93. doi: 10.1111/iwj.12005. Epub 2012 Nov 19.

  PMID: 23163982 BACKGROUND

• O'Connor, T. et al. in EWMA (Amsterdam, 2017).

  BACKGROUND

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  PMID: 22169081 BACKGROUND

• RCSI (2017) Introduction to Clinical Research and Good Clinical Practice Including Integrated Addendum to GCP Guidelines (E6 (R2) Version 4

  BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Bronchiolitis Obliterans Syndrome

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; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Tom O' Connor, DR.

  Royal College of Surgeons in Ireland

  PRINCIPAL INVESTIGATOR

• Declan Patton, DR

  Royal College of Surgeons in Ireland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caoimhe Joyce Hearne, BSc

CONTACT

0876631977; caoimhejoycehearne@rcsi.ie

Tom O' Connor, DR.

CONTACT

tomoconnor@rcsi.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Analysis of data will be blinded and carried out by a statistician. Patient data will be coded and not identifiable directly. The key to the code book information will be secured separately from the dataset in an encrypted file, which will only be accessible by the researcher and the supervisors of the study. Therefore the each arm will be coded and none identifiable to the outcome assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly allocated into an experimental arm and a control arm of the study. The experimental group will receive the adjunctive CUSECS treatment along their usual treatment for their diabetic ulcer twice weekly for 8 weeks using the BRH-A2 wound healing device. They will also have a follow up appointment 4 weeks after completion of treatment. The control group will be required to attend the diabetic foot clinic for their usual care for their diabetic foot ulcer with weekly review for a maximum of eight weeks. They will also have a follow up appointment 4 weeks after completion of treatment.

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 8, 2018
• Study Start: April 1, 2018
• Primary Completion: September 1, 2018
• Study Completion: October 1, 2018
• Last Updated: March 8, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share