NCT01101854

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 12, 2010

Completed
10.3 years until next milestone

Study Start

First participant enrolled

July 30, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2021

Completed
Last Updated

April 25, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

April 8, 2010

Last Update Submit

April 23, 2024

Conditions

Wounds and Injuries

Keywords

gene expression in woundshealing woundsnon-healing woundspunch biopsydebridement

Outcome Measures

Primary Outcomes (1)

  • Gene Expression Profiles

    A database of gene/protein/lipid expression and wound infection in healing and non-healing wounds.

    12 weeks

Secondary Outcomes (4)

  • Wound microbiome in healing and non-healing wounds

    12 weeks

  • Wound area at baseline vs 12 weeks

    12 weeks

  • Ultrasound images (per availability)

    12 weeks

  • Histopathological analysis in healing vs non-healing wounds

    12 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (19)

  • 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.

    PMID: 10687558BACKGROUND

  • 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.

    PMID: 10655791BACKGROUND

  • 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.

    PMID: 11448387BACKGROUND

  • 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.

    PMID: 15006880BACKGROUND

  • 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.

    PMID: 10333917BACKGROUND

  • 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.

    PMID: 11730224BACKGROUND

  • 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.

    PMID: 10836229BACKGROUND

  • 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.

    PMID: 14617286BACKGROUND

  • 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.

    PMID: 8598670BACKGROUND

  • 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.

    PMID: 15063699BACKGROUND

  • 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.

    PMID: 7636103BACKGROUND

  • 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.

    PMID: 15200237BACKGROUND

  • 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.

    PMID: 12952964BACKGROUND

  • 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.

    PMID: 12387859BACKGROUND

  • 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.

    PMID: 12078521BACKGROUND

  • 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.

    PMID: 15068823BACKGROUND

  • 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.

    PMID: 9843981BACKGROUND

  • 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.

    PMID: 15840707BACKGROUND

  • 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.

    BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Tissue

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Gayle Gordillo, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 8, 2010

First Posted

April 12, 2010

Study Start

July 30, 2020

Primary Completion

October 23, 2021

Study Completion

October 23, 2021

Last Updated

April 25, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)