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Extracorporeal Shockwave Therapy for Diabetic Foot Wounds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04042285
Recruitment Status : Recruiting
First Posted : August 1, 2019
Last Update Posted : August 1, 2019
Sponsor:
Collaborator:
University of Hull
Information provided by (Responsible Party):
Hull University Teaching Hospitals NHS Trust

Brief Summary:

Diabetic wounds post digital amputation have poor healing in 30-45% of cases, resulting in 75% of patients undergoing a further amputation within the year, despite best wound management.

Extracorporeal shockwave therapy is a promising safe and non invasive treatment that has been shown to improve healing in chronic ulcers and burns by promoting healing and decreasing risk of infection.

The study will recruit patients on a hospital ward who have undergone a toe amputation for a infected non healing diabetic foot ulcer. Participants will be informed about the study, given an patient information sheet and invited to give informed consent.

Consenting participants will undergo shockwave therapy three times in the seven days after their operation, in addition to standard wound care.

Wound measurements, blood perfusion, tissue integrity, quality of life and pain scores will be recorded at baseline, after the third treatment, 4 weeks, 8 weeks and 12 weeks after recruitment to the study.

The study aims to recruit 25 patients.

The results will be compared to a matched retrospective cohort group who received standard wound care.


Condition or disease Intervention/treatment Phase
Diabetic Foot Wound Device: Extracorporeal shockwave therapy Other: Standard Wound Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extracorporeal Shockwave Therapy for Diabetic Foot Wounds: A Cohort Study Comparing Extracorporeal Shockwave Therapy to Standard Treatment for Diabetic Foot Wounds
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Extracorporeal shockwave therapy
The shockwave therapy will be given at 120 pulses/cm2, penetration 5mm at a dose of 0.1mJ/mm2 at 5 pulses/second (17). Participants will receive 3 sessions of shockwave therapy in a 7-day period. In addition to standard wound care (dressing changes, negative pressure wound therapy, debridement, offloading footwear, glycaemic control and antibiotics, where appropriate).
Device: Extracorporeal shockwave therapy
Extracorporeal shockwave therapy will be given at 120 pulses/cm2, penetration 5mm at a dose of 0.1mJ/mm2 at 5 pulses/second. Participants will receive 3 sessions of shockwave therapy in a 7-day period.

Placebo Comparator: Standard wound care
Patient with a diabetic foot wound who receive standard wound care, consisting of dressing changes, negative pressure wound therapy, debridement, offloading footwear, glycaemic control and antibiotics, where appropriate.
Other: Standard Wound Care
dressing changes, negative pressure wound therapy, offloading footwear, debridement, glycaemic control and antibiotics as necessary




Primary Outcome Measures :
  1. Wound volume [ Time Frame: Baseline, up to 7 days, 4 weeks, 8 weeks, 12 weeks ]
    Change in wound volume between study visits


Secondary Outcome Measures :
  1. Pain Score Questionnaire [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]
    Brief Pain Inventory and Visual Analogue Scale

  2. Quality of Life Questionnaire [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]
    SF-12 and EQ-5Q-3L

  3. Infection rate [ Time Frame: Recorded at evey study contact ]
    The number of wounds which develop an infection in the study period

  4. Amputation rate [ Time Frame: Recorded at every study contact ]
    The number of amputations of treated sites in the study period

  5. Local perfusion rate [ Time Frame: Baseline, up to 7 days ]
    blood flow perfusion rate of superficial tissues using Doppler flowmetry

  6. Tissue integrity [ Time Frame: Baseline, up to 7 days ]
    Tissue hydration determined by a vapometer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of diabetes mellitus
  • Open surgical wound of the foot
  • ABPI >0.8
  • Age greater than 18 years old
  • Able and willing to give written informed consent
  • Be able to adhere to protocol and attend all follow up appointments

Exclusion Criteria:

  • Pregnancy or breast-feeding
  • Current malignancy
  • Allergy to materials used in the treatment
  • Palliative
  • Unable or unwilling to give consent
  • Anticoagulation

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): NCT04042285


Contacts
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Contact: Louise H Hitchman, MBBS +44 01482 674643 hylh@hyms.ac.uk
Contact: George E Smith, M.D +44 01482 674643 georgeedsmith@gmail.com

Locations
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United Kingdom
Hull and East Yorkshire Hospitals NHS Trust Recruiting
Hull, United Kingdom, HU3 2JZ
Contact: Louise Hitchman, MBBS    01482 674643    hylh@hyms.ac.uk   
Sponsors and Collaborators
Hull University Teaching Hospitals NHS Trust
University of Hull
Investigators
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Principal Investigator: George E Smith, M.D Academic Vascular Surgery Unit

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Responsible Party: Hull University Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT04042285    
Other Study ID Numbers: R2158
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hull University Teaching Hospitals NHS Trust:
Diabetic Foot Wound
Additional relevant MeSH terms:
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Diabetic Foot
Wounds and Injuries
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Anti-Bacterial Agents
Anti-Infective Agents