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Pilot study on the effect of tropocollagen injections on re-epithelialisation rate of hard-to-heal venous leg ulcers.

  • 2026-07-02
  • Journal of wound care 35(7)
    • Dorota Piechota
    • Marcela Nowak

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 20
Population
20 patients with hard-to-heal (chronic) granulating venous leg ulcers (VLUs)
Methods
Pilot study, patients randomly allocated to tropocollagen injections to wound edges (at 1cm intervals) every second week for two months vs debridement and same wound dressings without injections
Duration
two months

Objective

Collagen is a key component of the extracellular matrix, providing structural integrity and supporting tissue remodelling. Its biodegradability, biocompatibility and resistance to degradation make it ideal for biomedical applications, such as wound healing, tissue engineering and surgical adhesives. Collagen also plays a vital role in wound healing by supporting clot formation, attracting growth factors and promoting tissue regeneration. The aim of this study was to use the technique of tropocollagen injections and evaluate its effect on wound healing.

Method

In this pilot study, patients with hard-to-heal (chronic) granulating venous leg ulcers (VLUs), which were not infected or cancerous, underwent the procedure with tropocollagen injection to wound edges (at 1cm intervals), every second week for two months (the tropocollagen group). Patients were followed up every week over the two months and assessed for the percentage of wound that had re-epithelialised. Patients' pain levels were also noted using the Numerical Rating Scale (NRS). The same number of patients were treated as per those receiving the tropocollagen injections (debridement and same wound dressings but without the injections) to act as control.

Results

A total of 20 patients were randomly allocated to the two groups (10 in the tropocollagen group and 10 in the control group). The tropocollagen group demonstrated a higher rate of relative wound re-epithelialisation by day 30. On day 60, the tropocollagen group exhibited a significantly higher degree of wound re-epithelialisation compared with the control group (p<0.01). In three patients in the tropocollagen group, complete re-epithelialisation was observed at the end of the study period. Moreover, mean pain levels measured with NRS during dressing changes were only slightly higher in the tropocollagen group than in the control group (4.0 versus 3.0, respectively; p=0.03), yet significantly lower during rest (mean 2.0 versus 3.5±1.0, respectively; p=0.01).

Conclusion

The findings of this small study indicate that tropocollagen injections have a high potential to accelerate the re-epithelialisation of hard-to-heal VLUs that do not respond to other treatment methods. It is an effective method that can be used in outpatient settings, as an alternative to skin grafting.

Research Insights

  • Collagen Protein→Improved Wound Re-epithelialization

    The tropocollagen group demonstrated a higher rate of relative wound re-epithelialisation by day 30. On day 60, the tropocollagen group exhibited a significantly higher degree of wound re-epithelialisation compared with the control group (p<0.01).

    Effect
    Beneficial
    Effect size
    Moderate
  • Collagen Protein→Increased Pain

    mean pain levels measured with NRS during dressing changes were only slightly higher in the tropocollagen group than in the control group (4.0 versus 3.0, respectively; p=0.03)

    Effect
    Harmful
    Effect size
    Moderate
  • Collagen Protein→Reduced Pain During Rest

    yet significantly lower during rest (mean 2.0 versus 3.5±1.0, respectively; p=0.01)

    Effect
    Beneficial
    Effect size
    Moderate
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