diabetic foot ulcer and shock wave therapy

Phase 2

Completed

• Conditions: diabetic foot ulcer; Physical Medicine / Rehabilitation - Physiotherapy; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12613000355774
• Lead Sponsor: king Saud university, Rehabilitation Research Chair

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Patients who met the following criteria were included in this study: (1) diagnosis of type I and II diabetes; (2) Grade 2 diabetic foot ulcer (DFU) according to the University of Texas Diabetic Foot Wound Classification System (wound penetrating to tendon or capsule, not involving bone or joint); (3) ulcer has been resisted to conservative treatment > 3 months; (4) ulcer measures > 0.5cm and < 5 cm at any dimension; (5) patient should have had peripheral neuropathy, as defined by insensitivity to a 10-g monofilament and (6) patient should be willing to participate in the study and comply with the follow-up.

Exclusion Criteria

Patients were excluded if they had: (1) evidence of local infection, acute cellulitis, osteomyelitis or gangrene anywhere in the affected extremity; (2) presence of renal, hepatic, neurologic or malignant diseases; (3) severe protein malnutrition (serum albumin < 2.0 g/dl) or severe anemia (Hgb < 7.0 g/dl); (4) an ankle-brachial index < 0.7, absence of the dorsalis pedis or posterior tibial arteries pulse; or (5) pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified