Mechanisms Underlying Impaired Diabetic Wound Healing | NCT00777712

Studies
Mechanisms Underlying Impaired Diabetic Wound Healing

NCT00777712

Sponsor

University of Pittsburgh

Status

Recruiting

Last Update Posted

Jun 5, 2026Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Non-healing Wound

Interventions

Blood draw

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

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2008Actual

Primary Completion Date

Dec 31, 2029Estimated

Completion Date

Dec 31, 2030Estimated

First Submitted Date

Oct 21, 2008

First Submission Date that Met QC Criteria

Oct 21, 2008

First Posted Date

Oct 22, 2008Estimated

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

Jun 3, 2026

Last Update Posted Date

Jun 5, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The overall aim of this research is to utilize wound derived inflammatory cells from diabetic versus non diabetic human chronic wounds to understand mechanisms that are responsible for disregulated inflammation in individuals with diabetes. Biology of normal (peripheral blood derived cells) versus wound derived cells will also be studied.

Detailed Description

Specific aims:

To study biology of wound derived inflammatory cells and fluid from diabetic versus non diabetic wounds.
To characterize mechanisms that are responsible for dysregulated wound inflammatory cell function in individuals with diabetes.
To characterize differences in the biology of normal peripheral blood derived cells versus wound derived cells.

The long-term goal of this study is to determine the molecular mechanisms underlying impaired wound healing in diabetics.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chronic wound study		Patients with diabetes or no diabetes	Other: Blood draw

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood draw	Other	Blood will be drawn from subjects once and VAC sponge will be collected (which is normally discarded material per standard of care).	Chronic wound study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wound healing	Wound healing status	Week 16

Secondary Outcomes

Measure	Description	Time Frame
Infection status	CFU analysis of the wound fluid	week 0

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages 21-80
Chronic Wound (present >4 weeks)
Diabetic & Non-diabetic
Adult surgical wounds

Exclusion Criteria:

Inability to consent
Pregnant women
Therapeutically immunocompromised
Individuals defined in 45 CFR 46 Subparts B,C, and D, nor from any other population considered vulnerable 2.9

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients are being recruited at the UPMC Montefiore. The study started at the Ohio State University, and then moved to Indiana University before moving to University of Pittsburgh in 2023.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Piya Das Ghatak, PhD, MS	Contact	412-648-8297		pid12@pitt.edu
Urmila Gnyawali	Contact	4126240422		USG2@pitt.edu

Overall Officials

Name	Affiliation	Role
Sashwati Roy, Ph.D.	University of Pittsburgh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UPMC Montefiore	Recruiting	Pittsburgh	Pennsylvania	15219	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14618996	Background	Mousley M. Diabetes and its effect on wound healing and patient care. Nurs Times. 2003 Oct 21-27;99(42):70, 73-4.
9777971	Background	Stadelmann WK, Digenis AG, Tobin GR. Impediments to wound healing. Am J Surg. 1998 Aug;176(2A Suppl):39S-47S. doi: 10.1016/s0002-9610(98)00184-6.

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

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis