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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Chang Gung Memorial Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01219127
First received: October 10, 2010
Last updated: October 12, 2010
Last verified: February 2009
  Purpose

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 Intervention
Skin Ulcer
Other: Derma-PACE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Regeneration Effects of Derma-PACE Shockwave in Chronic Diabetic Ulcers

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • anticipate favorable results of derma-PACE ESWT in chronic diabetic ulcers than HBO [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 100
Study Start Date: February 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Ching-Jen Wang, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01219127     History of Changes
Other Study ID Numbers: 99-0438C, CMRPG880221
Study First Received: October 10, 2010
Last Updated: October 12, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Chang Gung Memorial Hospital:
Hyperbaric oxygen therapy

Additional relevant MeSH terms:
Ulcer
Skin Ulcer
Pathologic Processes
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014