N/A
N=24
Extracorporeal Shockwave Therapy for Diabetic Foot Wounds
Diabetic Foot · Wound
Bottom Line
View on ClinicalTrials.gov: NCT04042285 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Wound Volume — 1.16 cm^3
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Extracorporeal shockwave therapy in addition to standard care (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hull University Teaching Hospitals NHS Trust
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wound Volume |
1.16 | — |
| SECONDARY Pain Questionnaire |
1 | — |
| SECONDARY Quality of Life Questionnaires SF-12 |
59.78 | — |
| SECONDARY Infection Rate |
1 | — |
| SECONDARY Minor Amputation Rate |
2 | — |
| SECONDARY Local Perfusion Rate |
28.85 | — |
| SECONDARY Tissue Integrity |
21.53 | — |
| SECONDARY Quality of Life Questionnaire EQ5D3L |
0.81 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of diabetes mellitus
- Open 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
Data sourced from ClinicalTrials.gov (NCT04042285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.