Accidental WoundPhase 1NCT04219657
Comparison Between Skin Graft Versus Skin Graft and Stem Cell Application
A Phase 1 study testing mesenchymal stem cell application in people with Accidental Wound and Heel Injury, run by King Edward Medical University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Accidental Wound, Heel Injury, Stem Cell Transplant
- What is being tested?
- mesenchymal stem cell application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Oct 2016to 22 Dec 2019
- Phase
- Phase 1
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pediatric Surgery Department, King Edward Medical University
Lahore, Punjab Province, 54000
About this study
Official title: Comparison of Outcome of Mesenchymal Stem Cells And Skin Graft With Skin Graft In Management of Traumatic Heel Pad Injuries of Children
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.
Read the detailed description
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. These injuries can range from simple minor abrasions, lacerations to crushing of heel. Injury to heel pad and flap has serious impact in day to day life, causing disability because it is the major weight bearing area and inherently lacks adequate soft tissue.
Management of injury of heel pad in children depends on severity and extent of soft tissue injury. 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. Simple skin graft, lateral rotational skin flap, local muscle flaps, ingenious fasciocutaneous island flaps, cross-leg or cross foot flap, free tissue transfer and staged or distant jumped flaps are historically included in reconstructive ladder in repairing these soft tissue injuries. Generally, free flap reconstruction is the ultimate step of degloving wound coverage. Despite availability of various reconstructive techniques, covering of soft tissue loss of heel in traumatic events, remains a difficult and demanding procedure, especially when it is associated with fractures and complex wounds. Skin grafting offers poor functional and cosmetic results, although it is commonly performed with good take rates.
Stem cells are potential alternative to promote cutaneous wound healing because of its unique features like self-renewal and differentiation capacity. Mesenchymal stem cells are type of adult stem cells that reside in various tissues of the body. Besides, these cells are preferred for cell based therapies because they have immunomodulatory properties. These cells can be isolated from bone marrow, adipose tissue and human umbilical cord blood and tissue. Recently,umbilical cord derived mesenchymal stem cells have shown a tremendous potential for use in tissue engineering and regenerative medicine. Previous studies indicate that these mesenchymal stem cells can accelerate wound healing by enhanced proliferation and migration of human fibroblast, enhancing secretion of elastin, synthesizing collagen, angiogenesis and further maturing blood vessels present in wound site. Stem cell-based therapies will definitely be the major part of clinical medicine in next decade.
In the current study, 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. Considering the role of stem cells in wound healing, study has been designed to accelerate the wound healing process in children with 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, reducing the hospital stay and cost of treatment. Rationale of our study aims to compare outcome of heel pad injury managed with skin graft with infiltration of mesenchymal stem cell Versus management with skin graft only.
- Conditions
- Accidental Wound, Heel Injury, Stem Cell Transplant
- Being tested
- mesenchymal stem cell application
- Keywords
- spoke wheel injury, umbilical cord mesenchymal stem cells, skin grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesenchymal stem cell applicationBiological
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: mesenchymal stem cell application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 1st week of intervention and after at 12 weeks
Secondary outcomes (2)
duration of hospital stay
Hospital stay will be measured in terms of duration from date of admission to date of discharge from ward. The average hospital stay of children with heel pad injury with skin grafting is one month in pediatric surgery department in Mayo hospital, King Edward Medical University. In our study wound healing will be said better if hospital stay after skin graft/ flap with stem cell application will be less than one month.
Measured: from the date of admission to 2 weeks post admission
Weight bearing capacity of patients
Early weight bearing will be evaluated by pain intensity. Pain Score in this study will be measured by using Visual analogue scale (VAS). (Annex- 2) This scale is a valid tool for the measurement of pain intensity which has been widely used in diverse pediatric population. The scale is a continuous scale comprised of a horizontal or vertical line, usually 10 cm (100mm) in length, which is anchored by two extremes-no pain and worst possible pain. This scale is completed by treating consultant surgeon. Based on the distribution of visual analogue scale score in post-surgical patients, pain intensity is further classified as no pain, mild pain, moderate pain or severe pain with the cut points of 04mm, 5-44mm, 45-74mm and 75-100mm respectively.
Measured: at 1st week of intervention and after at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start29 Oct 2016
- Primary completion20 Dec 2019
- Study completion22 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Accidental WoundStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FATIMA NAUMERI, assoc Prof, Study director, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219657
- Sponsor's protocol ID
- Sushil_Rijal
- Status last verified
- Feb 2020
- First submitted
- 28 Dec 2019
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalam M, Faruquee S, Rahman S, Uddin H. Reconstruction of Heel: Options and Strategies. Bangladesh Journal of Plastic Surgery. 2010;1(1):14-8.
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.
Aslam MR, Khan AS, Pasha IF, Taj RU. Reconstruction of hind foot defects. Professional Medical Journal. 2013;20(4):606-16.
Lasanianos NG, Kanakaris NK. Soft Tissue Injuries. Trauma and Orthopaedic Classifications: Springer; 2015. p. 481-5
Meland NB. Microsurgical reconstruction: the weightbearing surface of the foot. Microsurgery. 1990;11(1):54-8. doi: 10.1002/micr.1920110111.
PubMed 1970110Lim 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.
PubMed 24665420Fathi 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.
PubMed 27574621Rodriguez 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.
PubMed 26645735Isakson 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.
PubMed 26106431Zhang 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.
PubMed 25638205
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcome of Mesenchymal Stem Cells And Skin Graft With Skin Graft In Management of Traumatic Heel Pad Injuries of Children
- ClinicalTrials.gov ID
- NCT04219657
- Acronym / sponsor ID
- Sushil_Rijal
- Conditions
- Accidental Wound, Heel Injury, Stem Cell Transplant
- Keywords
- spoke wheel injury, umbilical cord mesenchymal stem cells, skin grafting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 29 Oct 2016 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 22 Dec 2019 (actual)
- First posted
- 7 Jan 2020 (actual)
- 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.
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.
Detailed description
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. These injuries can range from simple minor abrasions, lacerations to crushing of heel. Injury to heel pad and flap has serious impact in day to day life, causing disability because it is the major weight bearing area and inherently lacks adequate soft tissue.
Management of injury of heel pad in children depends on severity and extent of soft tissue injury. 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. Simple skin graft, lateral rotational skin flap, local muscle flaps, ingenious fasciocutaneous island flaps, cross-leg or cross foot flap, free tissue transfer and staged or distant jumped flaps are historically included in reconstructive ladder in repairing these soft tissue injuries. Generally, free flap reconstruction is the ultimate step of degloving wound coverage. Despite availability of various reconstructive techniques, covering of soft tissue loss of heel in traumatic events, remains a difficult and demanding procedure, especially when it is associated with fractures and complex wounds. Skin grafting offers poor functional and cosmetic results, although it is commonly performed with good take rates.
Stem cells are potential alternative to promote cutaneous wound healing because of its unique features like self-renewal and differentiation capacity. Mesenchymal stem cells are type of adult stem cells that reside in various tissues of the body. Besides, these cells are preferred for cell based therapies because they have immunomodulatory properties. These cells can be isolated from bone marrow, adipose tissue and human umbilical cord blood and tissue. Recently,umbilical cord derived mesenchymal stem cells have shown a tremendous potential for use in tissue engineering and regenerative medicine. Previous studies indicate that these mesenchymal stem cells can accelerate wound healing by enhanced proliferation and migration of human fibroblast, enhancing secretion of elastin, synthesizing collagen, angiogenesis and further maturing blood vessels present in wound site. Stem cell-based therapies will definitely be the major part of clinical medicine in next decade.
In the current study, 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. Considering the role of stem cells in wound healing, study has been designed to accelerate the wound healing process in children with 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, reducing the hospital stay and cost of treatment. Rationale of our study aims to compare outcome of heel pad injury managed with skin graft with infiltration of mesenchymal stem cell Versus management with skin graft only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| skin grafting only | Experimental | Biological: mesenchymal stem cell applicationAll the cases in this group are managed with skin grafting only. Every odd case are kept in skin grafting only group. |
| skin grafting and stem cell group | Experimental | Biological: mesenchymal stem cell applicationAll 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mesenchymal stem cell application | Biological | skin grafting and stem cell group, skin grafting only |
Primary outcome
Ranges of Movement of ankle joint
Time frame: at 1st week of intervention and after at 12 weeks
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.
2 secondary outcomes
duration of hospital stay
Time frame: from the date of admission to 2 weeks post admission
Weight bearing capacity of patients
Time frame: at 1st week of intervention and after at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- BackgroundKalam M, Faruquee S, Rahman S, Uddin H. Reconstruction of Heel: Options and Strategies. Bangladesh Journal of Plastic Surgery. 2010;1(1):14-8.
- BackgroundGupta 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.
- BackgroundAslam MR, Khan AS, Pasha IF, Taj RU. Reconstruction of hind foot defects. Professional Medical Journal. 2013;20(4):606-16.
- BackgroundLasanianos NG, Kanakaris NK. Soft Tissue Injuries. Trauma and Orthopaedic Classifications: Springer; 2015. p. 481-5
- Background: PubMed 1970110Meland NB. Microsurgical reconstruction: the weightbearing surface of the foot. Microsurgery. 1990;11(1):54-8. doi: 10.1002/micr.1920110111.
- Background: PubMed 24665420Lim 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.
- Background: PubMed 27574621Fathi 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.
- Background: PubMed 26645735Rodriguez 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.
- Background: PubMed 26106431Isakson 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.
- Background: PubMed 25638205Zhang 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.
- 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.
FATIMA NAUMERI, assoc Prof study director
King Edward Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mesenchymal stem cell application in people with Accidental Wound and Heel Injury, run by King Edward Medical University at 1 site in Pakistan.
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: finished, as of the sponsor's last update on 17 Feb 2020. 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 Pakistan. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ranges of Movement of ankle joint (time frame: at 1st week of intervention and after at 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 NCT04219657, which also lists 10 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 17 Feb 2020.