Non-healing WoundWoundVACNCT00777712
Mechanisms Underlying Impaired Diabetic Wound Healing
An observational study of Non-healing Wound, run by University of Pittsburgh at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Non-healing Wound
- What is being tested?
- Blood draw
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2008to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- Ages 21-80
- Chronic Wound (present >4 weeks)
- Diabetic \& Non-diabetic
- Adult surgical wounds
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UPMC Montefiore
Pittsburgh, Pennsylvania, 15219
CeCe Zamarripa, RN, 412-647-7728, zamarripaca@upmc.edu
Piya Das Ghatak, PhD, 4126240422, piya.dasghatak@pitt.edu
- Recruiting
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15219
Cecilia Zamarripa, RN, 412-647-7728, zamarripaca@upmc.edu
Piya Das Ghatak, PhD, 412-648-8297, pid12@pitt.edu
About this study
Official title: Mechanisms Underlying Impaired Wound Healing
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.
Read the 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.
- Conditions
- Non-healing Wound
- Being tested
- Blood draw
- Keywords
- Wound healing, diabetes, inflammatory cell, monocyte, leukocyte, macrophage
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawOther
Blood will be drawn from subjects once and VAC sponge will be collected (which is normally discarded material per standard of care).
| Study group | Role | What they receive |
|---|---|---|
| Chronic wound study | Patients with diabetes or no diabetes Receives: Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
Wound healing status
Measured: Week 16
Secondary outcomes (1)
Infection status
CFU analysis of the wound fluid
Measured: week 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study start1 Sep 2008
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Non-healing WoundStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sashwati Roy, University of Pittsburgh
- Investigators
- Sashwati Roy, Ph.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777712
- Sponsor's protocol ID
- STUDY23070132
- Acronym
- WoundVAC
- Status last verified
- Jun 2026
- First submitted
- 21 Oct 2008
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Mousley M. Diabetes and its effect on wound healing and patient care. Nurs Times. 2003 Oct 21-27;99(42):70, 73-4.
PubMed 14618996Stadelmann 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.
PubMed 9777971Meehan M, O'Hara L, Morrison YM. Report on the prevalence of skin ulcers in a home health agency population. Adv Wound Care. 1999 Nov-Dec;12(9):459-67.
PubMed 10687558American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2007 Jan;30 Suppl 1:S42-7. doi: 10.2337/dc07-S042. No abstract available.
PubMed 17192378American Diabetes Association. Standards of medical care in diabetes--2007. Diabetes Care. 2007 Jan;30 Suppl 1:S4-S41. doi: 10.2337/dc07-S004. No abstract available.
PubMed 17192377
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms Underlying Impaired Wound Healing
- ClinicalTrials.gov ID
- NCT00777712
- Acronym / sponsor ID
- WoundVAC / STUDY23070132
- Conditions
- Non-healing Wound
- Keywords
- Wound healing, diabetes, inflammatory cell, monocyte, leukocyte, macrophage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 1 Sep 2008 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 22 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic wound study | – | Other: Blood drawPatients with diabetes or no diabetes |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (4 listed)
- Ages 21-80
- Chronic Wound (present >4 weeks)
- Diabetic \& Non-diabetic
- Adult surgical wounds
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawBlood will be drawn from subjects once and VAC sponge will be collected (which is normally discarded material per standard of care). | Other | Chronic wound study |
Primary outcome
Wound healing
Time frame: Week 16
Wound healing status
1 secondary outcome
Infection status
Time frame: week 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Background: PubMed 14618996Mousley M. Diabetes and its effect on wound healing and patient care. Nurs Times. 2003 Oct 21-27;99(42):70, 73-4.
- Background: PubMed 9777971Stadelmann 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.
- Background: PubMed 10687558Meehan M, O'Hara L, Morrison YM. Report on the prevalence of skin ulcers in a home health agency population. Adv Wound Care. 1999 Nov-Dec;12(9):459-67.
- Background: PubMed 17192378American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2007 Jan;30 Suppl 1:S42-7. doi: 10.2337/dc07-S042. No abstract available.
- Background: PubMed 17192377American Diabetes Association. Standards of medical care in diabetes--2007. Diabetes Care. 2007 Jan;30 Suppl 1:S4-S41. doi: 10.2337/dc07-S004. No abstract available.
- IU Center for Regenerative Medicine and Cell Based TherapiesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sashwati Roy, Ph.D. principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-healing Wound, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piya Das Ghatak, PhD, MS (412-648-8297, pid12@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00777712, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.