Effect of Platelet Concentrate in Treatment of Diabetic U... | NCT00215735

Studies
Effect of Platelet Concentrate in Treatment of Diabetic Ulcers

NCT00215735

Sponsor

Harvest Technologies

Status

Terminated

Last Update Posted

Mar 20, 2012Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Diabetes

Interventions

debridement, dressing, and APC

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

inconclusive results, market feasiblity

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

Sep 2005Actual

Completion Date

Sep 2005Actual

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2012

Last Update Posted Date

Mar 20, 2012Estimated

Description Module

Brief Summary

Autologous platelet concentrate will enhance the rate of healing of chronic diabetic wounds

Detailed Description

The treatment of a diabetic wound with APC and thrombinhas the potential to accelerate the re-epithial process when compared with usual care. The study is a prospective, randomized, blinded, multicenter clinical evaluation.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
APC Treatment	Experimental	wound debridement and treatment with APC	Device: debridement, dressing, and APC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
debridement, dressing, and APC	Device	ebridement, dressing, and APC	APC Treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:chronic diabetic ulcer -

Exclusion Criteria:steroids, dialysis, vascular disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Iafrati, MD	Tufts Medical Ctr	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Washington Regional Medical Center		Fayetteville	Alaska	72703	United States
Lucerne Hospital

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D014456	Ulcer

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003646	Debridement
D001458	Bandages
D057908	Argon Plasma Coagulation

Ancestor Terms

ID	Term
D013514	Surgical Procedures, Operative
D004864	Equipment and Supplies
D004564	Electrocoagulation
D002425	Cautery

Browse Leaves

Not provided

Browse Branches

Not provided