Consensus statement on the clinical application of extracorporeal shock wave therapy for diabetic foot ulcers (2025 Edition)Ovid

Journal: International Journal of Surgery, Volume 112, Pages 71‑83, January 2026 DOI:10.1097/JS9.0000000000003489Ovid Developed by: Wound Repair Committee, Chinese Medical Doctor Association; 69 multidisciplinary experts via Delphi methodOvid

Abstract

Diabetic foot ulcers (DFUs) represent one of the most severe late‑stage complications of diabetes mellitus and constitute a major therapeutic challenge. Extracorporeal shock‑wave therapy (ESWT) is a non‑invasive physical modality that promotes wound angiogenesis, regulates local inflammation, and accelerates granulation‑tissue formation and re‑epithelialization. Accumulating clinical evidence supports ESWT as an effective adjunct therapy for DFU healing. This consensus systematically summarizes the mechanism of action, indications, contraindications, standardized operational workflow, key technical parameters, post‑treatment assessment, complication prevention, and safety management of ESWT for DFUs. It aims to deliver practical clinical guidance for wound‑care, endocrinology, and rehabilitation clinicians managing adult patients with DFUs梅斯医学M....

Keywords: diabetic foot ulcer; extracorporeal shock wave therapy; wound healing; consensus statement

1. Mechanism of ESWT for DFUs

Shock‑wave mechanical stress triggers mechanotransduction in wound tissue:

1. Up‑regulate angiogenic factors (VEGF, eNOS) to improve local micro‑perfusion.
2. Modulate inflammatory response, shorten the inflammatory phase of chronic wounds.
3. Promote fibroblast proliferation, granulation‑tissue growth, and re‑epithelialization.
4. Reduce local nociceptive neuropeptides to relieve wound‑related pain.

Note: ESWT serves as adjuvant treatment, and cannot replace standard care including debridement, infection control, off‑loading, glycaemic control, and revascularization for ischaemic ulcers.

2. Indications (Evidence level / Recommendation strength)

Recommendation 1: ESWT can be routinely used for first‑onset Wagner grade 1‑2 DFUs. (A / Ⅰ)

Recommendation 2: ESWT may be applied for Wagner grade 3 DFUs after adequate debridement and drainage, provided no exposed bone, no active osteomyelitis, infection localized to wound surface or improved to Wagner 1‑2. (C / Ⅱb)Ovid

Recommendation 3: ESWT may be used for post‑amputation traumatic ulcers (Wagner 4‑5) without severe infection or gangrene. (C / Ⅱb)Ovid

Recommendation 4: For DFUs with sinus tracts, ESWT may be considered only after adequate drainage of deep abscess and exclusion of progressive osteomyelitis. (C / Ⅱb)

Recommendation 5: For DFUs combined with peripheral arterial disease (PAD): perform vascular assessment (ABI / TBI / TcPO₂). ESWT is allowed only after appropriate revascularization when tissue perfusion is restored. Do not apply ESWT to severe ischaemic ulcers without revascularization. (B / Ⅱa)

3. Absolute Contraindications

1. Active uncontrolled wound infection, necrotizing soft‑tissue infection.
2. Exposed bone with untreated osteomyelitis.
3. Severe limb ischaemia without revascularization.
4. Malignant lesions in target treatment area.
5. Pregnancy over the treatment site; haemorrhagic diathesis; ongoing anticoagulation with high bleeding risk.
6. Treatment over major nerve trunks, large vessels, open joint cavity.

Relative Contraindications: unstable glycaemia, severe peripheral oedema, extensive dry gangrene, severe pain poorly tolerated.

4. Modalities Selection

Recommendation 11: Radial‑ESWT (r‑ESWT) shows good efficacy for superficial soft‑tissue defects and is suitable for most DFU patients. (B / Ⅱa)Ovid

Recommendation 12: Focused‑ESWT (f‑ESWT) may be considered for deep wounds and sinus tracts; parameters should be individualized by wound feature and patient tolerance. (C / Ⅱb)Ovid

5. Standard technical parameters & workflow

1. Pre‑treatment: Complete wound assessment, debride necrotic tissue, control infection; assess perfusion, glycaemia, pain. Apply ultrasound gel over wound and surrounding peri‑wound skin; avoid direct probe compression onto exposed tendons/bone.
2. Energy setting: Low‑energy ESWT for wounds: energy flux density 0.03‑0.10 mJ/mm², pulse count 50‑150 pulses/cm² of wound area.
3. Treatment frequency: Twice weekly; 6‑12 sessions as one full therapeutic course.
4. Intra‑treatment: Monitor real‑time pain response; reduce energy if intolerable pain occurs.
5. Post‑treatment: Keep wound moist and covered; maintain standard off‑loading, metabolic control.

6. Post‑treatment assessment and termination criteria

• Evaluate wound area, granulation status, exudate, pain every 2‑4 weeks.
• If ≥50 % wound area reduction after one course: continue further sessions.
• If no improvement after 8‑12 sessions: discontinue ESWT and re‑evaluate wound aetiology (hidden osteomyelitis, unaddressed ischaemia, inadequate off‑loading).

7. Prevention and management of adverse events

• Common: transient local erythema, mild pain, subcutaneous petechiae; self‑resolving without special intervention.
• Rare: blistering, wound aggravation, haematoma. Manage by symptomatic wound care; pause ESWT until skin recovers.
• Severe adverse events are uncommon when performed with standardized parameters.

8. Multidisciplinary collaborative principle

ESWT must be embedded within full DFU standard management:

• Infection control, adequate debridement.
• Effective off‑loading for neuropathic ulcers.
• Vascular evaluation and revascularization for PAD.
• Optimize glycaemia, blood pressure, lipid and nutritional status.

ESWT should never replace core components of DFU care as recommended by IWGDF guidelines.

Core clinical take‑home messages

1. ESWT is an adjuvant therapy, not a substitute for debridement, off‑loading, infection control or revascularization.
2. Wagner 1‑2 ulcers are the best‑indicated population.
3. Osteomyelitis, exposed bone, uncontrolled severe infection and non‑revascularized critical ischaemia are absolute contraindications.
4. Discontinue ESWT if no obvious improvement after a complete course, re‑explore underlying causes of non‑healing.

Disclaimer: This consensus is expert‑based guidance for clinical reference only and does not replace individual clinical decision‑making.

Cross‑reference with IWGDF 2023 diabetic foot guideline

ESWT is categorized as an adjunct physical therapy; priority should always be given to infection management, adequate off‑loading, and peripheral arterial revascularization for DFU patients.