Wounds and InjuriesGeneScreenNCT01101854
Gene Expression Profiles in Healing and Non-Healing Wounds
An observational study of Wounds and Injuries, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to develop a database containing information about genes/proteins/fats as well as wound infections in both healing and non-healing wounds. Many wounds that do not heal are infected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2020to 23 Oct 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have a chronic wound(s) (defined as a wound that has been present for at least 4 weeks).
Who may be able to join
- Age: 18 years and above
- Ulcer duration of > 4 weeks
Who cannot join
- Pregnant females
- Receiving chemotherapy or radiation therapy for cancer
- Known or suspected malignancy of current study ulcer
Trial locations and contacts
1 site in 1 country.
United States1 site
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
About this study
The purpose of this study is to develop a database containing information about genes/proteins/fats as well as wound infections in both healing and non-healing wounds. Many wounds that do not heal are infected. This study will help us determine if there is a relationship between the types of infections and how well a wound heals. Identification of genes/proteins/lipids (fats) that help predict wound healing under specific wound healing conditions will enable health care practitioners to select more appropriate treatments, monitor the responses to those treatments, and figure out what standard treatments should be.
Read the detailed description
During the first study visit, information about participants, such as age, race and gender, medical history, including nutritional status, medications and dietary supplements, and genetic diseases in the participant's family will be collected. Smoking and tobacco status, alcohol consumption, and/or recreational drugs usage will be documented. Additionally, wound information, including wound measurements, infection history, cause, location, how long you have had the wound, etc, a digital photograph of the wound and ultrasound imaging (if available) will be obtained. Lab results, such as nutrition and blood sugar (if the subject has Diabetes Mellitus) levels will be obtained. If a blood sugar level is not available from the past 3 months, a finger stick will be performed to obtain the participant's hemoglobin A1c level. Lastly, debrided tissue and/or biopsies, wound fluid, and 20 cc of blood will be collected.
During second study visit, a digital image of the wound area will be taken and the wound will be evaluated for clinical signs of infection using a WIfI scale, as appropriate. Any new wound treatments, labs, and adverse events along with changes in medications and medical history since baseline will be documented. Additionally, debrided tissue and/or biopsies, wound fluid, and 20 cc of blood will be collected.
The final stage is the observation phase, which will last up to 12 weeks. The wound closure and/or area data will be recorded from the participant's medical record up to 12 weeks.
Potential Risks:
Biopsy and Debridement:
There may be some discomfort with the tissue biopsy procedure depending on the amount of sensation the subject has at the site of the wound. The wound site will be numbed by applying local anesthesia as appropriate to area being biopsied. The amount of pain that occurs with wound biopsy will vary from person to person, but all reasonable efforts will be made to minimize pain. The biopsy procedure is done within the boundaries of the existing wound to avoid giving the patient a separate new wound. Bleeding is a possible complication, but the risk is low for the small biopsies and is reduced by using local anesthetics with epinephrine, and silver nitrate sticks are available in each room to cauterize biopsy sites as needed. Infection is also a potential risk; however, wound tissue biopsies are routinely performed as the standard of care in the CWC to diagnose wound infection. The biopsy site will be appropriately monitored for infection by the provider managing the wound during routine wound clinic visits. No additional study specific risk is identified for debrided tissue as the procedure is performed as part of SoC.
Blood Draw:
Temporary discomfort from the needle stick, bruising, bleeding, and rarely, infection. To reduce the risk of infection, the research personnel will clean subject's arm with an antiseptic solution before any blood is drawn.
Hemoglobin A1c point-of-care testing:
The point-of-care testing for hemoglobin A1c test is low risk. Potential risks include minor and temporary pain or discomfort and bleeding. Prior to the finger prick, research staff will clean the finger to be pricked with an alcohol swab. Subjects will be provided with a cotton ball and/or band-aid to stop the bleeding, if there is any.
- Conditions
- Wounds and Injuries
- Keywords
- gene expression in wounds, healing wounds, non-healing wounds, punch biopsy, debridement
- Medical subject headings
- Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene Expression Profiles
A database of gene/protein/lipid expression and wound infection in healing and non-healing wounds.
Measured: 12 weeks
Secondary outcomes (4)
Wound microbiome in healing and non-healing wounds
Identify the difference in microbiome between healing and non-healing wounds.
Measured: 12 weeks
Wound area at baseline vs 12 weeks
Compare the wound area during baseline visit and 12 weeks later.
Measured: 12 weeks
Ultrasound images (per availability)
Capture ultrasound images to understand anatomical nature of healed and non-healing wounds.
Measured: 12 weeks
Histopathological analysis in healing vs non-healing wounds
Compare the differences in tissue from healing and non-healing wounds.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2010 (estimated)
- Study start30 Jul 2020
- Primary completion23 Oct 2021
- Study completion23 Oct 2021
Why it stopped: PI left Indiana University and has elected not to continue this project at new institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gayle Gordillo, Indiana University
- Investigators
- Gayle Gordillo, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101854
- Sponsor's protocol ID
- 1906520102
- Acronym
- GeneScreen
- Status last verified
- Feb 2024
- First submitted
- 8 Apr 2010
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meehan 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 10687558Pieper B, Templin TN, Dobal M, Jacox A. Wound prevalence, types, and treatments in home care. Adv Wound Care. 1999 Apr;12(3):117-26.
PubMed 10655791Gottrup F, Holstein P, Jorgensen B, Lohmann M, Karlsmar T. A new concept of a multidisciplinary wound healing center and a national expert function of wound healing. Arch Surg. 2001 Jul;136(7):765-72. doi: 10.1001/archsurg.136.7.765.
PubMed 11448387Coerper S, Wicke C, Pfeffer F, Koveker G, Becker HD. Documentation of 7051 chronic wounds using a new computerized system within a network of wound care centers. Arch Surg. 2004 Mar;139(3):251-8. doi: 10.1001/archsurg.139.3.251.
PubMed 15006880Kalani M, Brismar K, Fagrell B, Ostergren J, Jorneskog G. Transcutaneous oxygen tension and toe blood pressure as predictors for outcome of diabetic foot ulcers. Diabetes Care. 1999 Jan;22(1):147-51. doi: 10.2337/diacare.22.1.147.
PubMed 10333917Grolman RE, Wilkerson DK, Taylor J, Allinson P, Zatina MA. Transcutaneous oxygen measurements predict a beneficial response to hyperbaric oxygen therapy in patients with nonhealing wounds and critical limb ischemia. Am Surg. 2001 Nov;67(11):1072-9; discussion 1080.
PubMed 11730224Misuri A, Lucertini G, Nanni A, Viacava A, Belardi P. Predictive value of transcutaneous oximetry for selection of the amputation level. J Cardiovasc Surg (Torino). 2000 Feb;41(1):83-7.
PubMed 10836229Niinikoski J. Hyperbaric oxygen therapy of diabetic foot ulcers, transcutaneous oxymetry in clinical decision making. Wound Repair Regen. 2003 Nov-Dec;11(6):458-61. doi: 10.1046/j.1524-475x.2003.11610.x.
PubMed 14617286Padberg FT, Back TL, Thompson PN, Hobson RW 2nd. Transcutaneous oxygen (TcPO2) estimates probability of healing in the ischemic extremity. J Surg Res. 1996 Feb 1;60(2):365-9. doi: 10.1006/jsre.1996.0059.
PubMed 8598670Gordillo GM, Schlanger R, Wallace WA, Bergdall V, Bartlett R, Sen CK. Protocols for topical and systemic oxygen treatments in wound healing. Methods Enzymol. 2004;381:575-85. doi: 10.1016/S0076-6879(04)81037-1. No abstract available.
PubMed 15063699Patterson JA, Bennett RG. Prevention and treatment of pressure sores. J Am Geriatr Soc. 1995 Aug;43(8):919-27. doi: 10.1111/j.1532-5415.1995.tb05538.x. No abstract available.
PubMed 7636103Roy S, Rink C, Khanna S, Phillips C, Bagchi D, Bagchi M, Sen CK. Body weight and abdominal fat gene expression profile in response to a novel hydroxycitric acid-based dietary supplement. Gene Expr. 2004;11(5-6):251-62. doi: 10.3727/000000003783992289.
PubMed 15200237Roy S, Khanna S, Wallace WA, Lappalainen J, Rink C, Cardounel AJ, Zweier JL, Sen CK. Characterization of perceived hyperoxia in isolated primary cardiac fibroblasts and in the reoxygenated heart. J Biol Chem. 2003 Nov 21;278(47):47129-35. doi: 10.1074/jbc.M308703200. Epub 2003 Sep 2.
PubMed 12952964Roy S, Lado BH, Khanna S, Sen CK. Vitamin E sensitive genes in the developing rat fetal brain: a high-density oligonucleotide microarray analysis. FEBS Lett. 2002 Oct 23;530(1-3):17-23. doi: 10.1016/s0014-5793(02)03309-4.
PubMed 12387859Roy S, Khanna S, Bentley K, Beffrey P, Sen CK. Functional genomics: high-density oligonucleotide arrays. Methods Enzymol. 2002;353:487-97. doi: 10.1016/s0076-6879(02)53071-8. No abstract available.
PubMed 12078521
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression Profiles in Healing and Non-Healing Wounds
- ClinicalTrials.gov ID
- NCT01101854
- Acronym / sponsor ID
- GeneScreen / 1906520102
- Conditions
- Wounds and Injuries
- Keywords
- gene expression in wounds, healing wounds, non-healing wounds, punch biopsy, debridement
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left Indiana University and has elected not to continue this project at new institution.
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 23 Oct 2021 (actual)
- Study completion
- 23 Oct 2021 (actual)
- First posted
- 12 Apr 2010 (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 purpose of this study is to develop a database containing information about genes/proteins/fats as well as wound infections in both healing and non-healing wounds. Many wounds that do not heal are infected. This study will help us determine if there is a relationship between the types of infections and how well a wound heals. Identification of genes/proteins/lipids (fats) that help predict wound healing under specific wound healing conditions will enable health care practitioners to select more appropriate treatments, monitor the responses to those treatments, and figure out what standard treatments should be.
Detailed description
During the first study visit, information about participants, such as age, race and gender, medical history, including nutritional status, medications and dietary supplements, and genetic diseases in the participant's family will be collected. Smoking and tobacco status, alcohol consumption, and/or recreational drugs usage will be documented. Additionally, wound information, including wound measurements, infection history, cause, location, how long you have had the wound, etc, a digital photograph of the wound and ultrasound imaging (if available) will be obtained. Lab results, such as nutrition and blood sugar (if the subject has Diabetes Mellitus) levels will be obtained. If a blood sugar level is not available from the past 3 months, a finger stick will be performed to obtain the participant's hemoglobin A1c level. Lastly, debrided tissue and/or biopsies, wound fluid, and 20 cc of blood will be collected.
During second study visit, a digital image of the wound area will be taken and the wound will be evaluated for clinical signs of infection using a WIfI scale, as appropriate. Any new wound treatments, labs, and adverse events along with changes in medications and medical history since baseline will be documented. Additionally, debrided tissue and/or biopsies, wound fluid, and 20 cc of blood will be collected.
The final stage is the observation phase, which will last up to 12 weeks. The wound closure and/or area data will be recorded from the participant's medical record up to 12 weeks.
Potential Risks:
Biopsy and Debridement:
There may be some discomfort with the tissue biopsy procedure depending on the amount of sensation the subject has at the site of the wound. The wound site will be numbed by applying local anesthesia as appropriate to area being biopsied. The amount of pain that occurs with wound biopsy will vary from person to person, but all reasonable efforts will be made to minimize pain. The biopsy procedure is done within the boundaries of the existing wound to avoid giving the patient a separate new wound. Bleeding is a possible complication, but the risk is low for the small biopsies and is reduced by using local anesthetics with epinephrine, and silver nitrate sticks are available in each room to cauterize biopsy sites as needed. Infection is also a potential risk; however, wound tissue biopsies are routinely performed as the standard of care in the CWC to diagnose wound infection. The biopsy site will be appropriately monitored for infection by the provider managing the wound during routine wound clinic visits. No additional study specific risk is identified for debrided tissue as the procedure is performed as part of SoC.
Blood Draw:
Temporary discomfort from the needle stick, bruising, bleeding, and rarely, infection. To reduce the risk of infection, the research personnel will clean subject's arm with an antiseptic solution before any blood is drawn.
Hemoglobin A1c point-of-care testing:
The point-of-care testing for hemoglobin A1c test is low risk. Potential risks include minor and temporary pain or discomfort and bleeding. Prior to the finger prick, research staff will clean the finger to be pricked with an alcohol swab. Subjects will be provided with a cotton ball and/or band-aid to stop the bleeding, if there is any.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have a chronic wound(s) (defined as a wound that has been present for at least 4 weeks).
Key inclusion criteria (2 listed)
- Age: 18 years and above
- Ulcer duration of > 4 weeks
Key exclusion criteria (3 listed)
- Pregnant females
- Receiving chemotherapy or radiation therapy for cancer
- Known or suspected malignancy of current study ulcer
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
Gene Expression Profiles
Time frame: 12 weeks
A database of gene/protein/lipid expression and wound infection in healing and non-healing wounds.
4 secondary outcomes
Wound microbiome in healing and non-healing wounds
Time frame: 12 weeks
Wound area at baseline vs 12 weeks
Time frame: 12 weeks
Ultrasound images (per availability)
Time frame: 12 weeks
Histopathological analysis in healing vs non-healing wounds
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: PI left Indiana University and has elected not to continue this project at new institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- 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 10655791Pieper B, Templin TN, Dobal M, Jacox A. Wound prevalence, types, and treatments in home care. Adv Wound Care. 1999 Apr;12(3):117-26.
- Background: PubMed 11448387Gottrup F, Holstein P, Jorgensen B, Lohmann M, Karlsmar T. A new concept of a multidisciplinary wound healing center and a national expert function of wound healing. Arch Surg. 2001 Jul;136(7):765-72. doi: 10.1001/archsurg.136.7.765.
- Background: PubMed 15006880Coerper S, Wicke C, Pfeffer F, Koveker G, Becker HD. Documentation of 7051 chronic wounds using a new computerized system within a network of wound care centers. Arch Surg. 2004 Mar;139(3):251-8. doi: 10.1001/archsurg.139.3.251.
- Background: PubMed 10333917Kalani M, Brismar K, Fagrell B, Ostergren J, Jorneskog G. Transcutaneous oxygen tension and toe blood pressure as predictors for outcome of diabetic foot ulcers. Diabetes Care. 1999 Jan;22(1):147-51. doi: 10.2337/diacare.22.1.147.
- Background: PubMed 11730224Grolman RE, Wilkerson DK, Taylor J, Allinson P, Zatina MA. Transcutaneous oxygen measurements predict a beneficial response to hyperbaric oxygen therapy in patients with nonhealing wounds and critical limb ischemia. Am Surg. 2001 Nov;67(11):1072-9; discussion 1080.
- Background: PubMed 10836229Misuri A, Lucertini G, Nanni A, Viacava A, Belardi P. Predictive value of transcutaneous oximetry for selection of the amputation level. J Cardiovasc Surg (Torino). 2000 Feb;41(1):83-7.
- Background: PubMed 14617286Niinikoski J. Hyperbaric oxygen therapy of diabetic foot ulcers, transcutaneous oxymetry in clinical decision making. Wound Repair Regen. 2003 Nov-Dec;11(6):458-61. doi: 10.1046/j.1524-475x.2003.11610.x.
- Background: PubMed 8598670Padberg FT, Back TL, Thompson PN, Hobson RW 2nd. Transcutaneous oxygen (TcPO2) estimates probability of healing in the ischemic extremity. J Surg Res. 1996 Feb 1;60(2):365-9. doi: 10.1006/jsre.1996.0059.
- Background: PubMed 15063699Gordillo GM, Schlanger R, Wallace WA, Bergdall V, Bartlett R, Sen CK. Protocols for topical and systemic oxygen treatments in wound healing. Methods Enzymol. 2004;381:575-85. doi: 10.1016/S0076-6879(04)81037-1. No abstract available.
- Background: PubMed 7636103Patterson JA, Bennett RG. Prevention and treatment of pressure sores. J Am Geriatr Soc. 1995 Aug;43(8):919-27. doi: 10.1111/j.1532-5415.1995.tb05538.x. No abstract available.
- Background: PubMed 15200237Roy S, Rink C, Khanna S, Phillips C, Bagchi D, Bagchi M, Sen CK. Body weight and abdominal fat gene expression profile in response to a novel hydroxycitric acid-based dietary supplement. Gene Expr. 2004;11(5-6):251-62. doi: 10.3727/000000003783992289.
- Individual participant dataSharing planned: No
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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.
Gayle Gordillo, MD principal investigator
Indiana University
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 Wounds and Injuries, run by Indiana University 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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 25 Apr 2024. 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 was stopped early (reason given: PI left Indiana University and has elected not to continue this project at new institution.). Results are not available in the source record.
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.
What does the primary outcome measure?
Gene Expression Profiles (time frame: 12 weeks). 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 NCT01101854, which also lists 19 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 25 Apr 2024.