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

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ClinicalTrials.gov Identifier: NCT01219127
Recruitment Status : Unknown
Verified February 2009 by Chang Gung Memorial Hospital.
Recruitment status was:  Active, not recruiting
First Posted : October 13, 2010
Last Update Posted : October 13, 2010
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Skin Ulcer Other: Derma-PACE

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Regeneration Effects of Derma-PACE Shockwave in Chronic Diabetic Ulcers
Study Start Date : February 2009
Estimated Primary Completion Date : February 2011
Estimated Study Completion Date : February 2011
Arms and Interventions

Arm Intervention/treatment
Experimental: Derma-PACE
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
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.

Outcome Measures

Primary Outcome Measures :
  1. anticipate favorable results of derma-PACE ESWT in chronic diabetic ulcers than HBO [ Time Frame: 24 month ]
    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.

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

1.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

More Information

Responsible Party: Ching-Jen Wang, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01219127     History of Changes
Other Study ID Numbers: 99-0438C
CMRPG880221 ( Other Grant/Funding Number: Chang Gung Research Fund/CMRPG880221 )
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: October 13, 2010
Last Verified: February 2009

Keywords provided by Chang Gung Memorial Hospital:
Hyperbaric oxygen therapy

Additional relevant MeSH terms:
Skin Ulcer
Pathologic Processes
Skin Diseases