Diabetes MellitusEPCNCT00739323
Impaired Wound Healing in Diabetic Foot Ulceration
An observational study of Diabetes Mellitus and Healthy Volunteers, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
An observational study to gather information about people who may have certain abnormalities in skin microcirculation and muscle metabolism and to determine whether these abnormalities affect wound healing. The study also examines the association of a specific type of cell with the rate of wound healing. Read more about this study
- Who is it for?
- Ages 21 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Healthy Volunteers
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects may be selected from the Beth Israel Deaconess Foot Clinic or from the Boston area and surrounding locations.
Who may be able to join
- Current diagnosis of Type I or Type II Diabetes Mellitus.
- Ulcer present for minimum 4 weeks
- Have adequate circulation to the foot
- Can return for follow-up visits
- Be able to read and sign the Informed Consent form before enrollment
Who cannot join
- Active Charcot's foot ulcer on the foot to be studied
- Presence of any serious disease that can affect wound healing including end stage renal failure requiring hemodialysis or renal transplantation, active malignant disease requiring treatment, hepatic, hematologic, neurologic, or immune disease
- Alcohol or drug abuse problems
- Treatment with oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents
- Presence of infectious disease that can preclude EPC measurements (including HIV, Hepatitis B and C)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
An observational study to gather information about people who may have certain abnormalities in skin microcirculation and muscle metabolism and to determine whether these abnormalities affect wound healing. The study also examines the association of a specific type of cell with the rate of wound healing.
Read the detailed description
An observational study which entails: medical history; physical examination; blood tests; MRI; microcirculation tests (two noninvasive tests: 1) a procedure that measures the resting blood flow of the skin and 2) a technique that introduces acetylcholine and sodium nitroprusside in the skin and measures the ability of the skin's vessels to dilate and increase blood flow); and macrocirculation tests (noninvasive ultrasound of arm). This study also involves 2 Visits to the Beth Israel Deaconess Medical Center in Boston, MA. (Joslin-Beth Israel Deaconess Foot Center, Lowry Outpatient Laboratory, MRI Suite).
- Conditions
- Diabetes Mellitus, Healthy Volunteers
- Medical subject headings
- Diabetes Mellitus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startDec 2006
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aristidis Veves, Beth Israel Deaconess Medical Center
- Investigators
- Aristidis Veves, DSc, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739323
- Sponsor's protocol ID
- 2006P000335
- Other IDs
- R01DK076937, 1R01DK076937
- Acronym
- EPC
- Status last verified
- Feb 2017
- First submitted
- 19 Aug 2008
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impaired Wound Healing in Diabetic Foot Ulceration
- ClinicalTrials.gov ID
- NCT00739323
- Acronym / sponsor ID
- EPC / 2006P000335
- Conditions
- Diabetes Mellitus, Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Dec 2006
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 21 Aug 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.
An observational study to gather information about people who may have certain abnormalities in skin microcirculation and muscle metabolism and to determine whether these abnormalities affect wound healing. The study also examines the association of a specific type of cell with the rate of wound healing.
Detailed description
An observational study which entails: medical history; physical examination; blood tests; MRI; microcirculation tests (two noninvasive tests: 1) a procedure that measures the resting blood flow of the skin and 2) a technique that introduces acetylcholine and sodium nitroprusside in the skin and measures the ability of the skin's vessels to dilate and increase blood flow); and macrocirculation tests (noninvasive ultrasound of arm). This study also involves 2 Visits to the Beth Israel Deaconess Medical Center in Boston, MA. (Joslin-Beth Israel Deaconess Foot Center, Lowry Outpatient Laboratory, MRI Suite).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects may be selected from the Beth Israel Deaconess Foot Clinic or from the Boston area and surrounding locations.
Key inclusion criteria (5 listed)
- Current diagnosis of Type I or Type II Diabetes Mellitus.
- Ulcer present for minimum 4 weeks
- Have adequate circulation to the foot
- Can return for follow-up visits
- Be able to read and sign the Informed Consent form before enrollment
Key exclusion criteria (6 listed)
- Active Charcot's foot ulcer on the foot to be studied
- Presence of any serious disease that can affect wound healing including end stage renal failure requiring hemodialysis or renal transplantation, active malignant disease requiring treatment, hepatic, hematologic, neurologic, or immune disease
- Alcohol or drug abuse problems
- Treatment with oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents
- Presence of infectious disease that can preclude EPC measurements (including HIV, Hepatitis B and C)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
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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. This study is not recruiting at the moment.
Aristidis Veves, DSc principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Healthy Volunteers, run by Beth Israel Deaconess Medical Center at 1 site 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 1 Mar 2017.