Wound Healing DelayedNCT05326022
Microcurrent Therapy and Low-Level Laser Therapy on Wound Healing
A study testing Microcurrent therapy, Low Level Laser Therapy and Medical therapy in people with Wound Healing Delayed, run by Nehad Ahmed Youness Abo-zaid.
Trial summary
The study aiming to compare between the Microcurrent and Low-Level Laser Therapy on wound healing Read more about this study
- Who is it for?
- Ages 10 to 50 years, men only
- Conditions the study is for
- Wound Healing Delayed
- What is being tested?
- Microcurrent therapy, Low Level Laser Therapy and Medical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 28 Apr 2022to 30 Oct 2022
- Phase
- Interventional
- 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 10 to 50 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- patient recently undergo appendectomy
Who cannot join
- patient with neurological disorders
- patient with metabolic disorders
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Microcurrent Therapy Versus Low-Level Laser Therapy on Post-surgical Wound Healing
The study aiming to compare between the Microcurrent and Low-Level Laser Therapy on wound healing
Read the detailed description
The study designed to compare between the Microcurrent and Low-Level Laser Therapy on wound healing
- Conditions
- Wound Healing Delayed
- Being tested
- Microcurrent therapy, Low Level Laser Therapy, Medical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microcurrent therapyDevice
Microcurrent therapy
Low Level Laser TherapyDevice
Laser therapy
Medical therapyOther
Medical therapy
| Study group | Role | What they receive |
|---|---|---|
| medical therapy group | Experimental | formed of 20 patients to whom ordinary medical therapy as the pervious groups and placebo shame laser had been applied. Receives: Other: Medical therapy |
| medical therapy and Microcurrent group | Experimental | formed of 20 patients to whom the microcurrent therapy had been applied with ordinary medical therapy. Receives: Device: Microcurrent therapy; Other: Medical therapy |
| medical therapy and Low-Level Laser Therapy group | Experimental | formed of 20 patients to whom the Low Level Laser Therapy had been applied with ordinary medical therapy. Receives: Device: Low Level Laser Therapy; Other: Medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
levels of matrix metalloproteinases
analyze by Enzyme-linked immunosorbent assay
Measured: assessed at day 3 post operative
Secondary outcomes (3)
levels of matrix metalloproteinases
analyze by Enzyme-linked immunosorbent assay
Measured: assessed at day 30 post operative
the tissue inhibitors of metalloproteinases
analyze by Enzyme-linked immunosorbent assay
Measured: assessed at day 3 post operative
the tissue inhibitors of metalloproteinases
analyze by Enzyme-linked immunosorbent assay
Measured: assessed at day 30 post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start28 Apr 2022 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound Healing DelayedStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nehad Ahmed Youness Abo-zaid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nehad Ahmed Youness Abo-zaid, South Valley University
- Investigators
- Nehad A. Abo-Zaid, PhD, Principal investigator, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326022
- Sponsor's protocol ID
- P.T.REC/012/002599
- Status last verified
- Apr 2022
- First submitted
- 23 Mar 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dickinson LE, Gerecht S. Engineered Biopolymeric Scaffolds for Chronic Wound Healing. Front Physiol. 2016 Aug 5;7:341. doi: 10.3389/fphys.2016.00341. eCollection 2016.
PubMed 27547189
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcurrent Therapy Versus Low-Level Laser Therapy on Post-surgical Wound Healing
- ClinicalTrials.gov ID
- NCT05326022
- Acronym / sponsor ID
- P.T.REC/012/002599
- Conditions
- Wound Healing Delayed
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Nehad Ahmed Youness Abo-zaidUniversity, hospital or other
- Study start
- 28 Apr 2022 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 13 Apr 2022 (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.
The study aiming to compare between the Microcurrent and Low-Level Laser Therapy on wound healing
Detailed description
The study designed to compare between the Microcurrent and Low-Level Laser Therapy on wound healing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| medical therapy group | Experimental | Other: Medical therapyformed of 20 patients to whom ordinary medical therapy as the pervious groups and placebo shame laser had been applied. |
| medical therapy and Microcurrent group | Experimental | Device: Microcurrent therapy, Other: Medical therapyformed of 20 patients to whom the microcurrent therapy had been applied with ordinary medical therapy. |
| medical therapy and Low-Level Laser Therapy group | Experimental | Device: Low Level Laser Therapy, Other: Medical therapyformed of 20 patients to whom the Low Level Laser Therapy had been applied with ordinary medical therapy. |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patient recently undergo appendectomy
Key exclusion criteria (2 listed)
- patient with neurological disorders
- patient with metabolic disorders
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 |
|---|---|---|
| Microcurrent therapyMicrocurrent therapy | Device | medical therapy and Microcurrent group |
| Low Level Laser TherapyLaser therapy | Device | medical therapy and Low-Level Laser Therapy group |
| Medical therapyMedical therapy | Other | medical therapy and Low-Level Laser Therapy group, medical therapy and Microcurrent group, medical therapy group |
Primary outcome
levels of matrix metalloproteinases
Time frame: assessed at day 3 post operative
analyze by Enzyme-linked immunosorbent assay
3 secondary outcomes
levels of matrix metalloproteinases
Time frame: assessed at day 30 post operative
the tissue inhibitors of metalloproteinases
Time frame: assessed at day 3 post operative
the tissue inhibitors of metalloproteinases
Time frame: assessed at day 30 post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Background: PubMed 27547189Dickinson LE, Gerecht S. Engineered Biopolymeric Scaffolds for Chronic Wound Healing. Front Physiol. 2016 Aug 5;7:341. doi: 10.3389/fphys.2016.00341. eCollection 2016.
- 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.
Nehad A. Abo-Zaid, PhD principal investigator
South Valley University
Questions about this trial
What is this clinical trial studying?
A study testing Microcurrent therapy, Low Level Laser Therapy and Medical therapy in people with Wound Healing Delayed, run by Nehad Ahmed Youness Abo-zaid.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nehad A. Abo-Zaid, PhD (+201223265216, dr.nehadahmed@svu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
levels of matrix metalloproteinases (time frame: assessed at day 3 post operative). 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 NCT05326022, which also lists 1 linked publication.
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 13 Apr 2022.