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NCT Number: NCT05777213

Potential Injection of Human Umbilical Cord Secretome in the Case of Trophic Ulcers (Pre-post Intervention)

Background: Trophic ulcer is one of the complications that arise due to leprosy infection of the skin and includes diseases that trigger permanent disability and reduce the quality of life of the person. The facts in the field that more than 50% of chronic ulcers, especially trophic ulcers due to leprosy fail to heal with usual treatment. Therefore it is important to do a new method in healing trophic ulcers. Stem cell therapy or one of them is conditioned medium mesenchymal stem cell is a promising therapy because of its biological and physiological processes resembling the mechanism of wound healing Method: This research is a clinical trial research "Open Trial". Phase 1 to see the side effects caused by the intervention. Minimum sample size of 20 respondents with trophic ulcers due to leprosy that is difficult to resolve with usual treatment. The main outcome is wound healing in terms of the length and extent of the wound. The secondary outcome is treatment toxicity 4 weeks after administration. Follow-up visits will be scheduled at 2, 4, and 12 weeks post-treatment. If the results confirm safety, feasibility and potential efficacy, large multicenter randomized controlled trials with longer follow-up will begin with a focus on the effectiveness of therapy

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Key information

Conditions

Trophic Ulcer Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Leprosy Morbus Hansen Mycobacterium Infections Mycobacterium Infections, Nontuberculous

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sukma Clinic, Tangerang, Banten, Indonesia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic ulcers in Morbus Hansen's patients aged 18-80 years
  • Not recovering with routine therapy for at least 1 months
  • Trophic ulcers degrees 2 and 3
  • Willing to take part in the study
  • As well as with the respondent's good health to follow this study.

Exclusion criteria

  • Patients who took anticoagulants,
  • Patients had hypertension
  • Patients had any staging kidney failure
  • Patients had a history of blood disorders and pregnancy.

Treatment and study plan

Secretome

Biological

The interventions given in this study were Conditioned Medium Wharton's Jelly-derived mesenchymal stem cells (CM-WJMSCs) as much as 0.1cc / 1cm intracutaneously with a flexpen device in the wound area every 2 weeks. The variables in this study were divided into two, namely the independent variable was the use of Conditioned Medium Wharton's Jelly-derived mesenchymal stem cells (CM-WJMSCs) were administered intracutaneously, and the dependent variables were wound healing and side effects caused by the interventions given. Wound healing or repair in this study was assessed from several variables, namely the presence of granulation tissue growth, reduced edema, reduced erythema and improvement in wound size both in terms of length, width, and area measured by using a standard ruler and digital photo.

Primary outcomes

  1. Changes in Wound Size - Length

    Time frame: 4 weeks

    Digital measurements of Length carried out using a rule from time to time (1 time per week for 4 weeks) with units in cm

  2. Changes in Wound Size - Width

    Time frame: 4 weeks

    Digital measurements of Width carried out using a rule from time to time (1 time per week for 4 weeks) with units in cm

  3. Changes in Wound Size - Area

    Time frame: 4 weeks

    Digital measurements carried out by multiplying the length and width of the wound over time (1 time per week for 4 weeks) in units of cm squares

Other outcomes

  1. Adverse event of Allergic

    Time frame: 4 weeks

    Assessment of side effects in the form of allergies for 4 weeks the intervention is expressed in the form of incidence with consideration of diagnosis by a doctor and sought to know about the causal from these side effects

  2. Adverse event of Erythema

    Time frame: 4 weeks

    Assessment of side effects in the form of erythema for 4 weeks the intervention is expressed in the form of incidence with consideration of diagnosis by a doctor and searched for causal from these side effects

  3. Adverse event of Angioedema and Urticaria

    Time frame: 4 weeks

    Assessment of side effects in the form of Angioedema and Urticaria for 4 weeks the intervention is expressed in the form of incidence with consideration of diagnosis by a doctor and searched for causal from these side effects

  4. Adverse event of Tumor

    Time frame: 4 weeks

    Assessment of side effects in the form of Tumor for 4 weeks the intervention is expressed in the form of incidence with consideration of diagnosis by a doctor and searched for causal from these side effects

Sponsors and collaborators

Lead sponsor

Yohanes Firmansyah, dr, MH, MM

Other

Collaborators

  • Tarumanagara University

Registry information

Official study title

Effectiveness of Giving Injection of Human Umbilical Cord Secretome in the Case of Trophic Ulcers (Pre-post Intervention)

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Mar 21, 2023
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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