NCT04042285

Extracorporeal Shockwave Therapy for Diabetic Foot Wounds

Completed Results posted Last updated 28 March 2025

What this trial tests

trial testing Extracorporeal shockwave therapy in addition to standard care in Diabetic Foot in 24 participants. Completed in 13 May 2022.

Timeline

1 February 2019

Primary endpoint
2 February 2020

13 May 2022

Quick facts

Lead sponsor	Hull University Teaching Hospitals NHS Trust
Status	Completed
Study type	OBSERVATIONAL
Enrollment	24
Start date	1 February 2019
Primary completion	2 February 2020
Estimated completion	13 May 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

• Extracorporeal shockwave therapy in addition to standard care

Conditions studied

• Diabetic Foot — all drugs for Diabetic Foot →
• Wound — all drugs for Wound →

Sponsor

Hull University Teaching Hospitals NHS Trust

Who can join

18 and older, any sex, with Diabetic Foot or Wound. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Wound Volume Primary · 12 weeks

Change in wound volume between study visits

Group	Value	95% CI
Extracorporeal Shockwave Therapy	1.16	-1.8 – 4.12

Pain Questionnaire Secondary · 12 weeks

Brief Pain Inventory (BPI) - A person rates their pain on a scale of 0 to 10. The BPI scale defines pain as follows: Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.

Group	Value	95% CI
Extracorporeal Shockwave Therapy	1	± 0

Quality of Life Questionnaires SF-12 Secondary · 12 weeks

Quality of Life Questionnaire Short Form-12 (8 domains of questions) scored on a scale 1-5, where a low score is good health and a high score is poor health. Total scores range from 0 to100, with higher scores indicating better physical and mental health functioning.

Group	Value	95% CI
Extracorporeal Shockwave Therapy	59.78	± 6.13

Infection Rate Secondary · Recorded at 12 weeks

The number of wounds which develop an infection in the study period.

Group	Value	95% CI
Extracorporeal Shockwave Therapy	1

Minor Amputation Rate Secondary · Recorded at 12 weeks

The number of minor amputations of treated limbs in the study period.

Group	Value	95% CI
Extracorporeal Shockwave Therapy	2

Local Perfusion Rate Secondary · 7 days

Blood flow perfusion rate of superficial tissues using Doppler flowmetry, an increase in the number signifies an increase in bloodflow to the area. Doppler flowmetry measures the shift in frequency that occurs when light is scattered by the red blood cells moving through capillaries.

Group	Value	95% CI
Extracorporeal Shockwave Therapy	28.85	± 37.09

Tissue Integrity Secondary · 7 days

Tissue hydration determined by a vapometer, the sensor evaluates the efficiency of the human skin water barrier, a high score is a sign of increased tissue water loss, and therefore reduced tissue integrity.

Group	Value	95% CI
Extracorporeal Shockwave Therapy	21.53	± 12.93

Quality of Life Questionnaire EQ5D3L Secondary · 12 weeks

The EuroQoL-5D-5L is a brief, multiattribute, generic, health status measure composed of 5 questions with Likert response options. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state.

Group	Value	95% CI
Extracorporeal Shockwave Therapy	0.81	± 0.44

Sponsor's own description

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 and outpatient departments who have a diabetic foot wound. 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.