The Regeneration Effects of Derma-PACE Shockwave in Chronic Diabetic Ulcers

NCT01219127 | Unknown

• 2 other identifiers: 99-0438CCMRPG880221
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Management of chronic diabetic foot skin ulcers require multidisciplinary approaches including diabetic control, wound care, antibiotic, shoe wear off-loading, and surgery in selected cases. The results are inconsistent and irregular, and most studies reported unsatisfactory results. Many adjunctive therapies are implemented in the care of chronic diabetic foot ulcers including hyperbaric oxygen therapy (HBO), ultrasound, recombinant human platelet-derived growth factor-BB (rPDGF-BB), vacuum assisted wound closure (VAWC) and acellular matrix. HBO is the most commonly utilized at the investigators institution. Mixed results of HBO in chronic diabetic foot ulcers are reported. Several studies reported that the beneficial effects of HBO, but none showed universal success. Therefore, the development of a new effective method of treatment for chronic diabetic ulcers is extremely valuable. Extracorporeal shockwave therapy (ESWT) acts as mechanotransduction that produces the therapeutic benefits through complex biological pathways including neovascularization and tissue regeneration. ESWT also showed bacteriostatic effects in experiments. Some studies reported the effectiveness of ESWT in acute and chronic soft tissue wounds. Others reported effectiveness of ESWT in chronic ulcers with 50% completely healed with 6 sessions of treatment. With this background, it appears that ESWT may be effective in the treatment of chronic diabetic foot ulcers. The purpose of this study is to evaluate the efficacy of ESWT in chronic foot ulcers, and to compared with that treated with HBO, and to study the molecular and blood flow perfusion before and after ESWT.

Conditions

Skin Ulcer

Keywords

Hyperbaric oxygen therapy

Outcome Measures

Primary Outcomes (1)

• anticipate favorable results of derma-PACE ESWT in chronic diabetic ulcers than HBO

  We anticipate a favorable result with derma-PACE ESWT compared to HBO. This novel method of treatment may bring in a new insight in the management of chronic diabetic ulcers. Shockwave has the potential to cure chronic diabetic ulcers without surgery and directly benefits thousands of patients who suffer from this disastrous disease.

  24 month

Study Arms (1)

Derma-PACE

EXPERIMENTAL

Pre-treatment evaluations include complete history and physical examination, chemistry and coagulation profiles, detailed past surgical and medical treatments. The local findings of the ulcer are quantitatively assessed using the S(AD) SAD classification (6) including photo-documentation for the size, shape and configuration of the ulcer

Other: Derma-PACE

Interventions

Derma-PACE OTHER

ESWT group received derma-PACE shockwave treatment 2 x 1 wk for 3 wks for a total of 6 treatment using derma-PACE dervice (Alpharetta, GA). HBO groups received HBOT daily 5 days a week for 8 weeks or a total of 40 treatments.

Derma-PACE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• recurrent chronic diabetic and non-diabetic skin ulcers of the extremities for longer than 3 months duration.

You may not qualify if:

• patients with cardiac arrhythmia or pacemaker, pregnancy, skeletal immaturity patients with malignancy, patients with joint sepsis, ulcers around the skull, spine and chest wall, and patients with poor compliance

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Skin Ulcer

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 10, 2010
• First Posted: October 13, 2010
• Study Start: February 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: October 13, 2010

Record last verified: 2009-02