NCT04219657

Brief Summary

Trauma is the leading cause of soft tissue loss of the heel. Children constitute the largest group of victims of such injuries. Spoke wheel injury, road traffic accident are common mode in the children. Oestern and Tscherne have classified soft tissue injuries into four grades from 0-4. The treatment of Grade 0 and 1 injuries is typical cleansing and application of a moist wound healing dressing. But further grades need surgical management with debridement and reconstruction. Grade III and IV can be reconstructed by using graft, flaps or various other techniques. . Skin grafting offers poor functional and cosmetic results, although it is commonly performed with good take rates. mesenchymal stem cells will be isolated from umbilical cord with informed consent from the mothers. This study will open a new avenue for the treatment of heel pad injury. . Since the use of stem cell (especially in Pakistan) is completely a new technique in the management of heel pad injury, it will provide insight for better management by accelerating the wound healing process.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

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

October 29, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

3.1 years

First QC Date

December 28, 2019

Last Update Submit

February 13, 2020

Conditions

Accidental WoundHeel InjuryStem Cell Transplant

Keywords

spoke wheel injuryumbilical cord mesenchymal stem cellsskin grafting

Outcome Measures

Primary Outcomes (1)

  • Ranges of Movement of ankle joint

    Average Ranges of Motion of ankle joint as described by American Academy of Orthopedic Surgeons is Dorsiflexion 0-20 degrees and Plantarflexion 0-50 degrees. In our scoring system dorsiflexion upto20 degree will be given 5 score and 0 degree will be given 0 score. Similarly, plantar flexion beyond 40 degree will be given 5 and 0 degree will be given 0 score.

    at 1st week of intervention and after at 12 weeks

Secondary Outcomes (2)

  • duration of hospital stay

    from the date of admission to 2 weeks post admission

  • Weight bearing capacity of patients

    at 1st week of intervention and after at 12 weeks

Study Arms (2)

skin grafting only

EXPERIMENTAL

All the cases in this group are managed with skin grafting only. Every odd case are kept in skin grafting only group.

Biological: mesenchymal stem cell application

skin grafting and stem cell group

EXPERIMENTAL

All the cases in this group are managed with skin grafting and application of stem cells. every even cases are kept in skin grafting and stem cells group.

Biological: mesenchymal stem cell application

Interventions

mesenchymal stem cell applicationBIOLOGICAL
skin grafting and stem cell groupskin grafting only

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pediatric age group population (less than 12 years) irrespective of sex.
  • Children with traumatic heel pad injury requiring skin grafting admitted through outdoor and emergency department.

You may not qualify if:

  • Children with traumatic heel pad injury associate with other systemic injury requiring surgical/medical treatment other than skin graft/flap.
  • Traumatic heel pad injury with calcaneal fracture.
  • Children with traumatic heel pad injury with osteomyelitis, Idiopathic thrombocytopenic purpura, diabetes mellitus and immunodeficiency state under medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Surgery Department, King Edward Medical University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (10)

  • Kalam M, Faruquee S, Rahman S, Uddin H. Reconstruction of Heel: Options and Strategies. Bangladesh Journal of Plastic Surgery. 2010;1(1):14-8.

    BACKGROUND

  • Gupta H, Shrestha R. Bicycle-spoke injuries of the foot and ankle: A prospective study. Journal of College of Medical Sciences-Nepal. 2014;9(4):36-9.

    BACKGROUND

  • Aslam MR, Khan AS, Pasha IF, Taj RU. Reconstruction of hind foot defects. Professional Medical Journal. 2013;20(4):606-16.

    BACKGROUND

  • Lasanianos NG, Kanakaris NK. Soft Tissue Injuries. Trauma and Orthopaedic Classifications: Springer; 2015. p. 481-5

    BACKGROUND

  • Meland NB. Microsurgical reconstruction: the weightbearing surface of the foot. Microsurgery. 1990;11(1):54-8. doi: 10.1002/micr.1920110111.

    PMID: 1970110BACKGROUND

  • Lim H, Han DH, Lee IJ, Park MC. A Simple Strategy in Avulsion Flap Injury: Prediction of Flap Viability Using Wood's Lamp Illumination and Resurfacing with a Full-thickness Skin Graft. Arch Plast Surg. 2014 Mar;41(2):126-32. doi: 10.5999/aps.2014.41.2.126. Epub 2014 Mar 12.

    PMID: 24665420BACKGROUND

  • Fathi HR, Fathi M, Javid MJ. S-shaped reverse sural flap for reconstruction of tissue defect on heel. Burns Trauma. 2013 Jun 18;1(1):39-43. doi: 10.4103/2321-3868.113334. eCollection 2013.

    PMID: 27574621BACKGROUND

  • Rodriguez J, Boucher F, Lequeux C, Josset-Lamaugarny A, Rouyer O, Ardisson O, Rutschi H, Sigaudo-Roussel D, Damour O, Mojallal A. Intradermal injection of human adipose-derived stem cells accelerates skin wound healing in nude mice. Stem Cell Res Ther. 2015 Dec 8;6:241. doi: 10.1186/s13287-015-0238-3.

    PMID: 26645735BACKGROUND

  • Isakson M, de Blacam C, Whelan D, McArdle A, Clover AJ. Mesenchymal Stem Cells and Cutaneous Wound Healing: Current Evidence and Future Potential. Stem Cells Int. 2015;2015:831095. doi: 10.1155/2015/831095. Epub 2015 May 27.

    PMID: 26106431BACKGROUND

  • Zhang J, Guan J, Niu X, Hu G, Guo S, Li Q, Xie Z, Zhang C, Wang Y. Exosomes released from human induced pluripotent stem cells-derived MSCs facilitate cutaneous wound healing by promoting collagen synthesis and angiogenesis. J Transl Med. 2015 Feb 1;13:49. doi: 10.1186/s12967-015-0417-0.

    PMID: 25638205BACKGROUND

Study Officials

  • FATIMA NAUMERI, assoc Prof

    King Edward Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
cases included in study were randomly divided into two group. patients were masked about group. Every odd patients were kept in group A and every Even patients were kept in group B.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Cases were divided into two groups. Group A included cases with skin graft only and group B included cases with skin graft and application of mesenchymal stem cells. Every odd patients were kept in group A and every Even patients were kept in group B.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2019

First Posted

January 7, 2020

Study Start

October 29, 2016

Primary Completion

December 20, 2019

Study Completion

December 22, 2019

Last Updated

February 17, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)