Gene Expression Profiles in Healing and Non-Healing Wounds (GeneScreen)

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.

Study Overview

• Status: Recruiting
• Conditions: Wounds and Injuries

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 Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

• Study Contact: Name: Bryce Hockman, CCRP; Phone Number: 317 278 2715; Email: bbhockma@iu.edu
• Study Contact Backup: Name: Kaitlyn Depinet, FNP-C; Phone Number: 317 278 2747; Email: kdepinet@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • IU Health Methodist Hospital
      • Principal Investigator: Gayle Gordillo, MD
      • Sub-Investigator: Chandan Sen, PhD
      • Sub-Investigator: Sashwati Roy, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who have a chronic wound(s) (defined as a wound that has been present for at least 4 weeks).

Description

Inclusion Criteria:

• Age: 18 years and above
• Ulcer duration of > 4 weeks

Exclusion Criteria:

• Pregnant females
• Receiving chemotherapy or radiation therapy for cancer
• Known or suspected malignancy of current study ulcer

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gene Expression Profiles	A database of gene/protein/lipid expression and wound infection in healing and non-healing wounds.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound microbiome in healing and non-healing wounds	Identify the difference in microbiome between healing and non-healing wounds.	12 weeks
Wound area at baseline vs 12 weeks	Compare the wound area during baseline visit and 12 weeks later.	12 weeks
Ultrasound images (per availability)	Capture ultrasound images to understand anatomical nature of healed and non-healing wounds.	12 weeks
Histopathological analysis in healing vs non-healing wounds	Compare the differences in tissue from healing and non-healing wounds.	12 weeks

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Gayle Gordillo, MD, Indiana University

Publications and helpful links

General Publications

• Niinikoski 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.
• 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.
• Coerper 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.
• Pieper B, Templin TN, Dobal M, Jacox A. Wound prevalence, types, and treatments in home care. Adv Wound Care. 1999 Apr;12(3):117-26.
• Gottrup 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.
• Kalani 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.
• Grolman 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.
• Misuri 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.
• Padberg 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.
• Gordillo 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.
• Patterson 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.
• Roy 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.
• Roy 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.
• Roy 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.
• Roy 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.
• Liu-Stratton Y, Roy S, Sen CK. DNA microarray technology in nutraceutical and food safety. Toxicol Lett. 2004 Apr 15;150(1):29-42. doi: 10.1016/j.toxlet.2003.08.009.
• Eisen MB, Spellman PT, Brown PO, Botstein D. Cluster analysis and display of genome-wide expression patterns. Proc Natl Acad Sci U S A. 1998 Dec 8;95(25):14863-8. doi: 10.1073/pnas.95.25.14863.
• Pawitan Y, Michiels S, Koscielny S, Gusnanto A, Ploner A. False discovery rate, sensitivity and sample size for microarray studies. Bioinformatics. 2005 Jul 1;21(13):3017-24. doi: 10.1093/bioinformatics/bti448. Epub 2005 Apr 19.
• Efron B, Tibshirani R, Storey JD, Tusher V. Empirical Bayes Analysis of a Microarray Experiment. Journal of the American Statistical Association. 2001; 96(456):1151-1160.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: April 8, 2010
• First Submitted That Met QC Criteria: April 9, 2010
• First Posted (Estimate): April 12, 2010

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: debridement; non-healing wounds; punch biopsy; gene expression in wounds; healing wounds
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 1906520102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No