Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
The CareFUL Prevention Trial (CareFULPrevent)
This study is not yet open for participant recruitment.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), December 2008
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00803608
  Purpose

To assess the efficacy of TrueContour Insoles versus the current standard of care insoles in recurrence of plantar ulcers in men and women, 18 years of age or older at the time of consent with clinical diagnosis of Diabetes Mellitus type 1 or type 2 who have had at least one recently healed plantar foot ulcer (>1 week but <12 weeks since heeling) and have Loss of Protective Sensation.


Condition Intervention Phase
Plantar Ulcer
Diabetes
Loss of Protective Sensation
Device: True Contour Insole
Device: Standard Insole
Phase II

MedlinePlus related topics: Diabetes Foot Health
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind (Subject), Parallel Assignment
Official Title: Prospective, Randomized, Multiple Site Clinical Trial Comparing the Effectiveness of Novel Pressure Based Insoles to Current Care For Ulcer Prevention

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • The first occurrence of a plantar ulcer or pre-ulcer in subjects who have had one previously healed plantar ulcer [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 286
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
02: Active Comparator
Current standard of care insole
Device: Standard Insole
Current SADMERC approved insole
01: Experimental
True Contour insole
Device: True Contour Insole
Novel designed insole

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women, 18 years of age or older at the time of consent;
  2. Clinical diagnosis of Diabetes Mellitus type 1 or type 2;
  3. At least one recently healed plantar foot ulcer (>1 week but <12 weeks since heeling);
  4. Loss of Protective Sensation
  5. Community ambulatory or better by patient report?;
  6. Ability to give consent;
  7. In the opinion of the investigator the subject is willing and able to comply with the scheduled visits, treatment plan, and other trial procedures for the duration of the study.

Exclusion Criteria:

  1. The subject has a current ulcer below the malleoli;
  2. The subject has partial amputation
  3. The subject has an active Charcot process;
  4. The subject has barefoot plantar pressure in the area of the previously healed ulcer <450 kPa (<300 kPa for toe ulcers);
  5. The subject has need for more complex intervention, i.e. the local decision that patient needs a rigid outsole;
  6. The subject has had a prior ulcer on the plantar aspect of the heel
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00803608

Contacts
Contact: Alesia N Aileo, BS 814-234-0700 aaileo@diapedia.com
Contact: Marty Bradley 814-234-0700 mbradley@diapedia.com

Sponsors and Collaborators
Investigators
Principal Investigator: Joseph L Loomis, MS DIApedia, LLC
  More Information

Responsible Party: DIApedia, LLC ( Joseph Loomis )
Study ID Numbers: DK05907405A1
Study First Received: December 4, 2008
Last Updated: December 4, 2008
ClinicalTrials.gov Identifier: NCT00803608  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Plantar
Ulcer
Diabetes

Study placed in the following topic categories:
Foot Ulcer
Skin Diseases
Ulcer
Diabetes Mellitus
Skin Ulcer
Foot Diseases
Leg Ulcer

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2009