Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00017384

Trial Description

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Title

Comparative analysis of the pH-value in acute and chronic wounds

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Trial Acronym

WOUND-pH

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Valid diagnostic tools for wound healing assesement, prediction of healing and monitoring of orderly progression in acute and chronic wound healing as well as indication of early healing disturbance are still lacking.
Nonetheless defined, robust and reproducible diagnostic marker and tools are desirable for future development and guidance of therapies especially in chronic wound management as well as study designs.

The pH-value is a marker, that might be potentially useful for monitoring the healing process and predict early local infection and stagnation of healing progress.

Using a handheld certified medical device, this study aims to evaluate the value of routine monitoring of the pH-value in chronic wounds compared to acute wounds. These data shall clarify the current inconsistent knowledge on the pH-value in different types of wounds (chronic Vs. acute, as well ass different chronic wound entities), during the course of wound healing and impaired healing as well as in wound infection manifestation.

Therefore, this multicenter open, epidemiological-observational study in patients with acute and chronic wounds was designed.

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Brief Summary in Scientific Language

Wound healing is a complex process, precisely regulated and modulated on several levels and dividable into overlapping phases (hemostasis and coagulation, inflammation, epithelialization and maturation). Regulatory and modulatory aspects are divers, yet include genexpression (transcription and translation), post-translational regulation (miRNA), available and active proteins (enzymes, cytokines, signaling proteins, mediators, growth factors, etc.) as well as external influencing factors such as the microbial conlonisation and therapeutic interventions.

In case of persistently non-healing wounds, the precisely regulated healing process is disturbed on one or more levels due to underlying pathologic conditions (diabetes, arterial or venous insufficieny, mechanical pressure, etc.) or external negative influences (infection, incorrect or insufficient therapy), resulting in wound chronification

Valid diagnostic tools for wound healing assesement, prediction of healing and monitoring of orderly progression in acute and chronic wound healing as well as indication of early healing disturbance are still lacking.
Nonetheless defined, robust and reproducible diagnostic marker and tools are desirable for future development and guidance of therapies especially in chronic wound management as well as study designs.

The pH-value is a marker, that might be potentially useful for monitoring the healing process and predict early local infection and stagnation of healing progress.

Using a handheld certified medical device, this study aims to evaluate the value of routine monitoring of the pH-value in chronic wounds compared to acute wounds. These data shall clarify the current inconsistent knowledge on the pH-value in different types of wounds (chronic Vs. acute, as well ass different chronic wound entities), during the course of wound healing and impaired healing as well as in wound infection manifestation.

Therefore, this multicenter open, epidemiological-observational study in patients with acute and chronic wounds was designed.

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Organizational Data

  •   DRKS00017384
  •   2019/07/25
  •   [---]*
  •   yes
  •   Approved
  •   14/2018, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Chronic wounds
  •   Acute wounds
  •   I70.24 -  [generalization I70.2: Atherosclerosis of arteries of extremities]
  •   I70.25 -  [generalization I70.2: Atherosclerosis of arteries of extremities]
  •   I87.21 -  [generalization I87.2: Venous insufficiency (chronic)(peripheral)]
  •   I83.0 -  Varicose veins of lower extremities with ulcer
  •   I83.2 -  Varicose veins of lower extremities with both ulcer and inflammation
  •   L97 -  Ulcer of lower limb, not elsewhere classified
  •   L89.1 -  Stage II decubitus ulcer
  •   L89.2 -  Stage III decubitus ulcer
  •   L89.3 -  Stage IV decubitus ulcer
  •   L89.9 -  Decubitus ulcer and pressure area, unspecified
  •   E11.74 -  [generalization E11.7: Type 2 diabetes mellitus; With multiple complications]
  •   E11.75 -  [generalization E11.7: Type 2 diabetes mellitus; With multiple complications]
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Interventions/Observational Groups

  •   Chronic wounds (duration > 8 weeks or considered chronic due to underlying condition)
  •   Acute wound (duration < 7 days)
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

Comparison pH-value of chronic Vs. acute wounds (data acquisition using medical device, pseudonymised CRF from routine data)

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Secondary Outcome

Comparison between different chronic wound entities, comparison infected/inflamed Vs. non-infected/inflamed, comparison healing Vs. non-healing, correlation analysis with regard to underlying medical conditions and therapeutic intervention

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2018/11/20
  •   520
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Man and women, 18 years or older
2. Written informed consent is provided
3. Presence of a wound
a) over 8 weeks in duration without adequate healing progression (‚chronic‘) or based on the underlying disease (diabetic, vascular or decubital ulceration)
b) less than 7 days postoperative / posttraumatic (‚acute‘)

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Exclusion Criteria

1. Dry necrotic wounds
2. Wounds < 1.5 cm2 in size
3. Underaged patients (< 18 years)
4. Pregnancy and nursing period
5. Wounds of malignant origin (i.e. malignant soft tissue tumor)
6. Missing informed consent

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Addresses

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Sources of Monetary or Material Support

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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.