Extracorporeal Shockwave Therapy for Diabetic Foot Ulcers

NCT05380544 | Active Not Recruiting DMC

• 3 other identifiers: R2743301807311664
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Summary of the problem: Diabetes has been described as the fastest growing health crisis of our time. It currently affects more than 4.5million people in the UK. The direct cost to the NHS is already over £1 billion per year. One of the commonest complications of diabetes are foot ulcers. Despite current best treatment, these ulcers can be very difficult to heal, often taking months to heal and some never do. Even after healing ulcers return in up to 60% of people. In England someone undergoes an amputation of part of their foot every 2 hours and every 4 hours someone loses their leg due to diabetic foot ulcers. People are rarely able to be as active as before. This seriously affects their work, finances and quality of life. Research into improved treatments are a national priority. These treatments need to be safe, effective, tolerable for patients and value for money. Preliminary research has identified shockwave therapy as a promising new treatment in which high-power soundwaves (similar to ultrasound) are delivered to the ulcer. This may make ulcers heal faster. However, the effectiveness of shockwave therapy and the optimum dose is unknown. The aim of the study:

1. 1.To carry out a preliminary (pilot) trial comparing sham (not active) shockwaves, low number of shockwaves and high number of shockwaves on diabetic foot ulcer healing
2. 2.To understand beliefs, concerns, ideas and experience of shockwave therapy amongst patients and clinicians
3. 3.To investigate the cost effectiveness (value for money) of shockwave therapy
4. 4.High dose shockwave treatment
5. 5.Low dose shockwave treatment
6. 6."Sham" shockwave treatment

Conditions

Diabetic Foot

Outcome Measures

Primary Outcomes (7)

• Eligibility ratio and recruitment ratio

  Number eligible patients/number patients screened / recruited

  19 months

• Adherence to treatment

  Number participants who completed the treatment protocol/number participants in the trial.

  19 months

• Percentage of missing data at each follow up point

  Number of missing data points over number of data points x100

  24 weeks

• Follow up rates

  No. of participants who attended each follow-up appointments / no. of follow-up appointments .

  6 weeks

• Follow up rates

  No. of participants who attended each follow-up appointments / no. of follow-up

  12 weeks

• Follow up rates

  No. of participants who attended each follow-up appointments / no. of follow-up

  24 weeks

• Patient and clinician acceptability of the trial process and ESWT

  Semi-structured in depth interviews

  24 weeks

Secondary Outcomes (10)

• Time to DFU healing

  24 weeks

• Proportion of DFUs healed at 6 months

  24 weeks

• Reduction in ulcer size at each study visit

  24 weeks

• Quality of life questionnaires

  24 weeks

• Quality of life questionnaires

  24 weeks

Study Arms (3)

Sham shockwave therapy

SHAM COMPARATOR

Sham shockwave therapy in standard ulcer care.

Device: Extracorporeal Shockwave Therapy

Low dose shockwave therapy

ACTIVE COMPARATOR

100 shocks per cm2 plus standard ulcer care

Device: Extracorporeal Shockwave Therapy

High dose shockwave therapy

ACTIVE COMPARATOR

500 shocks per cm2 plus standard ulcer care

Device: Extracorporeal Shockwave Therapy

Interventions

Extracorporeal Shockwave Therapy DEVICE

ESWT will be given at 0.1mJ/mm2, 5 pulses/second and penetration of 5mm. Each intervention will be delivered in 3x30minute sessions over 7 days.

High dose shockwave therapy; Low dose shockwave therapy; Sham shockwave therapy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least one unhealed diabetic foot ulcer below the level of the medial malleoli that has been present for more than 4 weeks
• Absolute toe pressure greater than or equal to 50mmHg or an Ankle Pressure Brachial Index (ABPI) equal to or greater than 0.7(24, 25)
• Capacity to consent to participate in the trial and given written informed consent
• Willing to be randomised to either sham, low-dose or high-dose ESWT
• Willing to consent to photography of the index DFU
• Willing to comply with the follow up schedule

You may not qualify if:

• Interdigital index ulcer. This is because the ESWT delivery paddle does not fit between digits.
• Currently on or planned treatment for osteomyelitis.
• Currently taking any therapeutic anticoagulation medications. This includes novel oral anticoagulants, therapeutic doses of heparin and vitamin-K antagonists. This is a contraindication to ESWT.
• Diagnosis of malignancy in the treatment area or haematological, disseminated or lymphatic malignancy. This is a contraindication to ESWT.
• All who are pregnant, trying to conceive or breastfeeding. This is a contraindication to ESWT.
• Active participants in other trials that may conflict with the study outcomes, for example any other wound care trials.

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Hull University Teaching Hospitals NHS Trust

Hull, HU3 2JZ, United Kingdom

Location

Related Publications (1)

• Hitchman L, Iglesias C, Russell D, Smith G, Twiddy M, Chetter IC. A Pilot Three Arm Randomised Controlled Trial and Qualitative Study of Extracorporeal Shockwave Therapy for Diabetic Foot Ulcer Healing (SOLEFUL): A Study Protocol. Int Wound J. 2025 Apr;22(4):e70176. doi: 10.1111/iwj.70176.

  PMID: 40159429 DERIVED

MeSH Terms

Conditions

Diabetic Foot

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Louise Hitchman, MBBSMRCSMSc

  Hull York Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Use of sham therapy for participant. Blinded outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Pilot RCT and Qualitative study

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: May 19, 2022
• Study Start: April 13, 2022
• Primary Completion: October 31, 2023
• Study Completion (Estimated): May 1, 2032
• Last Updated: October 2, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data shared dependent on request, following study completion.
• Access Criteria: Formal written letter to the PI.

Locations

GB (1)