NCT03239457

Brief Summary

The purpose of this study is to assess the efficacy and safety of the intralesional administration of Heberprot-P® (human recombinant epidermal growth factor) plus the standard treatment in patients with complex diabetic foot and risk of major amputation in Kuwait.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2015

Shorter than P25 for all trials

Status
completed

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

Study Start

First participant enrolled

December 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2017

Completed
Last Updated

August 4, 2017

Status Verified

May 1, 2016

Enrollment Period

2 months

First QC Date

August 1, 2017

Last Update Submit

August 1, 2017

Conditions

Diabetic Foot

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with 100% of the lesion area covered by granulation tissue.

    Lesion area granulation will be assessed as: Non response (0%-25%); Minimal (25%-50%); Partial (50%-75%); Total (75%-100%)

    The total duration of patient participation in the study will be 8 weeks for intervention or earlier if they show 100% granulation. Patients will be followed up until 20 weeks for final assessment

Secondary Outcomes (3)

  • Time in which the formation of the granulation tissue 100%

    8 weeks

  • Need of major amputation

    20 weeks

  • Adverse events

    20 weeks

Study Arms (1)

Heberprot P treatment

Patients with diabetic foot ulcers treated with Heberprot P

Biological: Heberprot P

Interventions

Heberprot PBIOLOGICAL

75 µg vials administered at the rate of a vial 3 times per week (Sunday Tuesday, Thursday) by intralesional and perilesional route.For this, the reconstitution and dilution of the vial will be carried out with 5 mL of water for injection. The administrations will be kept up to 8 weeks of treatment or until there is achieved granulation of the 100 % of the lesion.

Also known as: Human recombinant Epidermal Growth Factor
Heberprot P treatment

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Residents of the State of Kuwait attending to Dasman Diabetes Institute with Diabetic foot ulcer (DFU)

You may qualify if:

  • Diagnosis of diabetic foot ulcer,University of Texas Wound Classification AI-AII and CI-CII with or without ischemia at least of 4 weeks of evolution Ulcers with an area between ≥ 2 cm2 or greater (after sharp debridement of free, non-viable, hyperkeratotic and fibrotic tissue) Patients with age than 22 years. Voluntariness of the patient by signing up the informed consent, and written form signed the date prior to study.

You may not qualify if:

  • Hemoglobin ≤100 g/L. Patients with a significant acute cardiovascular event (Major Acute Cardiovascular Event) within 3 months prior such as acute myocardial infarction, severe angina pectoris, acute stroke or transient ischemic attack, and/or thrombo-embolism event.
  • Patients with chronic uncompensated diseases: diabetic coma, or renal failure (creatinine 200 mmol/L and oligoanuria).
  • Antecedents or suspicion of malignant diseases (general physical examination, rectal tact, examination of breast, abdominal ultrasound, thorax radiography and blood hemochemistry).
  • Psychiatric diseases that compromise the treatment or the evaluations Infection Pregnancy or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (19)

  • Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047.

    PMID: 15111519BACKGROUND

  • Boulton AJ, Kirsner RS, Vileikyte L. Clinical practice. Neuropathic diabetic foot ulcers. N Engl J Med. 2004 Jul 1;351(1):48-55. doi: 10.1056/NEJMcp032966. No abstract available.

    PMID: 15229307BACKGROUND

  • Frykberg RG, Zgonis T, Armstrong DG, Driver VR, Giurini JM, Kravitz SR, Landsman AS, Lavery LA, Moore JC, Schuberth JM, Wukich DK, Andersen C, Vanore JV; American College of Foot and Ankle Surgeons. Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg. 2006 Sep-Oct;45(5 Suppl):S1-66. doi: 10.1016/S1067-2516(07)60001-5.

    PMID: 17280936BACKGROUND

  • Reiber GE. The epidemiology of diabetic foot problems. Diabet Med. 1996;13 Suppl 1:S6-11. No abstract available.

    PMID: 8741821BACKGROUND

  • Lipsky BA. Medical treatment of diabetic foot infections. Clin Infect Dis. 2004 Aug 1;39 Suppl 2:S104-14. doi: 10.1086/383271.

    PMID: 15306988BACKGROUND

  • Dinh TL, Veves A. A review of the mechanisms implicated in the pathogenesis of the diabetic foot. Int J Low Extrem Wounds. 2005 Sep;4(3):154-9. doi: 10.1177/1534734605280130.

    PMID: 16100096BACKGROUND

  • Simmons Z, Feldman EL. Update on diabetic neuropathy. Curr Opin Neurol. 2002 Oct;15(5):595-603. doi: 10.1097/00019052-200210000-00010.

    PMID: 12352003BACKGROUND

  • Reiber GE, Vileikyte L, Boyko EJ, del Aguila M, Smith DG, Lavery LA, Boulton AJ. Causal pathways for incident lower-extremity ulcers in patients with diabetes from two settings. Diabetes Care. 1999 Jan;22(1):157-62. doi: 10.2337/diacare.22.1.157.

    PMID: 10333919BACKGROUND

  • Lavery LA, Armstrong DG, Murdoch DP, Peters EJ, Lipsky BA. Validation of the Infectious Diseases Society of America's diabetic foot infection classification system. Clin Infect Dis. 2007 Feb 15;44(4):562-5. doi: 10.1086/511036. Epub 2007 Jan 17.

    PMID: 17243061BACKGROUND

  • Brem H, Sheehan P, Boulton AJ. Protocol for treatment of diabetic foot ulcers. Am J Surg. 2004 May;187(5A):1S-10S. doi: 10.1016/S0002-9610(03)00299-X.

    PMID: 15147985BACKGROUND

  • Williams DT, Hilton JR, Harding KG. Diagnosing foot infection in diabetes. Clin Infect Dis. 2004 Aug 1;39 Suppl 2:S83-6. doi: 10.1086/383267.

    PMID: 15306984BACKGROUND

  • Eldor R, Raz I, Ben Yehuda A, Boulton AJ. New and experimental approaches to treatment of diabetic foot ulcers: a comprehensive review of emerging treatment strategies. Diabet Med. 2004 Nov;21(11):1161-73. doi: 10.1111/j.1464-5491.2004.01358.x.

    PMID: 15498081BACKGROUND

  • COHEN S. Isolation of a mouse submaxillary gland protein accelerating incisor eruption and eyelid opening in the new-born animal. J Biol Chem. 1962 May;237:1555-62. No abstract available.

    PMID: 13880319BACKGROUND

  • Cohen S, Carpenter G. Human epidermal growth factor: isolation and chemical and biological properties. Proc Natl Acad Sci U S A. 1975 Apr;72(4):1317-21. doi: 10.1073/pnas.72.4.1317.

    PMID: 1055407BACKGROUND

  • Cohen S, Carpenter G, King L Jr. Epidermal growth factor-receptor-protein kinase interactions. Prog Clin Biol Res. 1981;66 Pt A:557-67.

    PMID: 6273929BACKGROUND

  • Gospodarowicz D. Epidermal and nerve growth factors in mammalian development. Annu Rev Physiol. 1981;43:251-63. doi: 10.1146/annurev.ph.43.030181.001343. No abstract available.

    PMID: 7011183BACKGROUND

  • Gross I, Dynia DW, Rooney SA, Smart DA, Warshaw JB, Sissom JF, Hoath SB. Influence of epidermal growth factor on fetal rat lung development in vitro. Pediatr Res. 1986 May;20(5):473-7. doi: 10.1203/00006450-198605000-00018.

    PMID: 3487067BACKGROUND

  • Brown GL, Curtsinger L 3rd, Brightwell JR, Ackerman DM, Tobin GR, Polk HC Jr, George-Nascimento C, Valenzuela P, Schultz GS. Enhancement of epidermal regeneration by biosynthetic epidermal growth factor. J Exp Med. 1986 May 1;163(5):1319-24. doi: 10.1084/jem.163.5.1319.

    PMID: 3486247BACKGROUND

  • Cohen S, Carpenter G, King L Jr. Epidermal growth factor-receptor-protein kinase interactions. Co-purification of receptor and epidermal growth factor-enhanced phosphorylation activity. J Biol Chem. 1980 May 25;255(10):4834-42.

    PMID: 6246084BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Rafael Ibargollín Ulloa, MD, MSc

    Cuban Center for Genetic Engineering and Biotechnology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2017

First Posted

August 4, 2017

Study Start

December 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

August 4, 2017

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share